Recovery

NIH Challenge Grants

NHLBI Participation in NIH Challenge Grants in Health and Science Research (RFA-OD-09-003)

NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 – 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.

The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.

Broad Challenge Areas and Specific Challenge Topics

Note: Those marked with an asterisk (*) are the highest priority topics; however, applicants may apply to any of the topics. Please note also that the published topics reflect the Institute's views regarding priority areas that should be funded through the RC1 mechanism. It is possible, however, that an application focusing on a topic outside the listed priority areas will be found to be so compelling that the Institute will consider funding it.

For the National Heart, Lung, and Blood Institute, the Challenge Topics are:

(01) Behavior, Behavioral Change, and Prevention

01-HL-101 Develop innovative technologies and measurements to assess and provide real-time feedback on behavioral and environmental exposures for disease onset and progression for heart, lung, and blood diseases. In the area of risk factors, tools and measures are needed to assess dietary habits, physical activity, and psychological stress. Current approaches mostly rely on self-report and are, therefore, of limited reliability and validity while also being costly and imposing a high respondent burden. In the area of clinical outcomes, tools and measures are needed to assess early contributions to health care disparities and patient and provider adherence to medical regimens. Contact: Lawrence Fine, M.D., 301-435-0305, lf128x@nih.gov

(02) Bioethics

02-HL-101 Informing the ethical and practical guidelines for providing genetic research results to study participants. Following completion of the Human Genome Project, genome-wide association studies, candidate gene studies, and sequencing studies have proliferated and are now providing significant, clinically-relevant, and sometimes actionable, findings for study participants. However, investigators are at a loss with respect to ethical and practical issues to consider in providing results to study participants. Research is needed to inform the development of guidelines that could be followed by investigators who confront the issues of who, what, when and how genetic research results should be provided to study participants. Contact: Dr. Paul Sorlie, 301-435-0456, sorliep@nhlbi.nih.gov

02-OD(OSP)-101* Unique Ethical Issues Posed by Emerging Technologies. Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g. biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NHLBI Contact: Dr. Gail Weinmann, 301-435-0233, weinmanng@nhlbi.nih.gov

02-OD(OSP)-102* Ethical Issues in Health Disparities and Access to Participation in Research. Research is needed to assess the under-representation in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence, to identify barriers to participation in research and to develop approaches for overcoming them. Additionally, studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NHLBI Contact: Dr. Patrice Desvigne-Nickens, 301-435-0515, desvignp@nhlbi.nih.gov

02-OD(OSP)-103* Ethical Issues Associated with Electronic Sharing of Health Information. The development of an electronic health information infrastructure and the sharing of health information for patient care and research offer enormous promise to improve health care and promote scientific advances. However, the broad sharing of such data raises numerous ethical issues that may benefit from additional studies (e.g. those related to privacy and confidentiality). Examples include studies to assess risks associated with health information technology and the broad sharing of health information for research, and novel approaches for mitigating them. Examination could also include analysis of current oversight paradigms and suggestions for enhancements, as well as assessments of how privacy risks may change in the future. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NHLBI Contact: Dr. Dina Paltoo, 301-435-0513, paltood@nhlbi.nih.gov

02-OD(OSP)-104* Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice. Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NHLBI Contact: Dr. Dina Paltoo, 301-435-0513, paltood@nhlbi.nih.gov

02-OD(OSP)-105* Ethical Issues Raised by the Blurring between Treatment and Research. The distinction between clinical practice and research is growing less clear, a trend that may be more pronounced with respect to genetic information and medical records research. Studies are needed to better understand the ethical issues associated with this trend. Examples of studies include those to identify how this blurring in roles affects traditional human subjects protections, including, for example, essential practices such as informed consent, conceptions of the doctor/patient and investigator/subject relationship, and privacy protections. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NHLBI Contact: Dr. Carol Blaisdell, 301-435-0219, blaisdellcj@nhlbi.nih.gov

(03) Biomarker Discovery and Validation

03-HL-101* Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction. Treatment paradigms have evolved from studies of patients who, despite similar presentations, may have experienced disparate environmental exposures or clinical courses and may have varied underlying pathobiologies. As a result, patients who appear to be similar because of their clinical characteristics often demonstrate substantially different morbidity, mortality, and responses to drugs. Identification and validation of biomarkers from cell culture to animal models and human studies that can be efficiently and reproducibly quantified in a clinical setting could be used to determine the most effective care for individual patients and identify more precisely those who are most likely to benefit from specific interventions for prevention or treatment. Contact: Dr. James Kiley, 301-435-0233, kileyj@nhlbi.nih.gov

03-HL-102 Identify molecular addresses (zip codes) in blood vessels to enable specifically targeted therapy. Every organ appears to display a unique signature or molecular address (“zip code”) on the luminal surface of its blood vessels that can serve as a target for agents such as peptides, small molecules, or nanoparticles. Such agents could be used as carriers to transport drugs, genes, or imaging markers to diseased tissues/organs while sparing normal tissues. Contact: Dr. Stephen Goldman, 301-435-0560, goldmans@nhlbi.nih.gov

01-OD(OBSSR)-101* Tools for studying cultural phenomena. Development of new tools for: the measurement of culturally-shared mental phenomena (e.g., representations, scripts, prejudices); studying mechanisms by which these phenomena are transferred and adapted across individuals; and advancing research on the distribution and transmission of cultural phenomena within populations. OBSSR contact: Christine Bachrach, 301-496-9485, cbachrach@nih.gov; NHLBI Contact: Dr. Catherine Stoney, 301-435-6670, stoneyc@nhlbi.nih.gov

03-OD(OBSSR)-101* Developing high-throughput biomarker assays from finger-stick dried blood spots. Develop, using finger-stick dried blood spots, novel high-throughput biomarker assays, to identify lipids, proteins, metabolites, and genetic information to expand the array of available biomarkers for use in large community-based biosocial surveys. OBSSR contact: Kay Wanke, 301-435-3718, wankek@od.nih.gov; NHLBI Contact: Dr. Catherine Stoney, 301-435-6670, stoneyc@nhlbi.nih.gov

(04) Clinical Research

04-HL-101 Identify Mechanisms Linking Cardiopulmonary Disease Risk and Sleep Disordered Breathing. Sleep Disordered Breathing (SDB) is pervasive among the overweight and elderly; it more than doubles their risk of cardiovascular disease, stroke, respiratory problems, diabetes, and all-cause mortality. However, gaps in translational research defining how SDB treatment reduces cardiopulmonary morbidity have led to inconsistencies in whether SDB is treated in the course of usual cardiopulmonary care. Clinical approaches need to be applied to elucidate biomarkers, mechanisms, and clinically relevant pathways from animal models, clinical studies, and/or existing cohorts. Advances are urgently needed to move recent discoveries into practical application and improve cardiopulmonary disease outcomes. Contact: Dr. Michael Twery, 301-435-0199, twerym@nhlbi.nih.gov

04-HL-102 Develop Integrative Strategies to Elucidate the Mechanisms of Lung Diseases. Integrative approaches are needed to move beyond the limitations of traditional disease models based on single pathway/gene analyses. Studies are needed to elucidate biologically relevant patterns of cellular pathophysiology as a dynamic process and identify gene regulatory networks that control such processes as normal lung alveolization and development or that contribute to dysregulated vascular cell proliferation in pulmonary hypertension. Data developed through such studies are expected to support the development of molecular models for the study of lung cell interactions, the lung tissue injury cascade, immunophenotypes of lung disease, identification of regulatory and shared “control points” in the systems biology of lung disease, and molecular elements that predict disease susceptibility and therapeutic response. Contact: Dr. Dorothy Gail, 301-435-0222, gaild@nhlbi.nih.gov

04-HL-103 Assess the role of leukocyte interaction with platelets, erythrocytes, and endothelium in the pathogenesis of heart, lung, and blood diseases. The intercellular interface that emerges among leukocytes, platelets, and endothelial cells as a result of inflammation enables transfer of both beneficial and potentially injurious locally generated bioactive molecules. The mechanisms for recruitment, activation and retention of platelets and leukocytes and the associated sequelae on the behavior of endothelium and underlying tissue cells require more in-depth analysis. The identification of the key points controlling such communication may lead to new pharmaceutical interventions for both thrombosis and inflammation. Contact: Dr. Andrei Kindzelski, 301-402-0658, kindzelskial@mail.nih.gov

04-HL-104 Perform secondary analyses of existing data to answer important clinical and preventive medicine research questions. Numerous data sets have been created from completed and ongoing population-based longitudinal observational studies and clinical trials that include rich data on phenotypes, behaviors, genetic markers, environmental factors, physiological risk factors, subclinical cardiovascular disease, clinical care, and clinical outcomes. Those data sets may be not only be mined further to explore new hypotheses but also combined to increase statistical power and representativeness of the study populations. Selective addition of new data, such as data extracted from medical records of participants or data on costs, has the potential to provide valuable new information to the existing data. Efforts are needed to obtain additional data, combine data sets where appropriate, conduct additional analyses, and disseminate findings of clinical importance. Examples of areas of interest include:

Analysis of data from completed randomized clinical trials that may have ascertained atrial fibrillation to identify potential prevention approaches
Determination of cost-effectiveness of preventive interventions
Identification of prevention approaches or analyses of important demographic subgroups
Analysis of risk factors for heart failure
Identification of biomarkers for clinical outcomes, such as heart failure and atrial fibrillation
Evaluation of predictors of recurrent clinical cardiovascular disease
Exploration of associations of treatment and control of risk factors with severity of incident clinical events, recurrent clinical events, and prognosis
Analysis of genetic markers related to risk factors and disease in relation to their genetic and environmental context and how these may be used to inform preventive medicine and clinical care. Contact: Dr. Diane Bild, 301-435-0457, bildd@nhlbi.nih.gov

04-TW-101 Examining the clinical and mechanistic link between diabetes mellitus and cardiovascular disease in low- and middle-income countries. The rising epidemic of obesity, insulin resistance, and type 2 diabetes has placed societies at dramatically elevated risks for atherosclerotic disease. Epidemiologic studies involving global populations exposed to different environmental and genetic risk will improve understanding of the complex clinical and mechanistic links between diabetes and heart disease, and help create the next generation of control measures. Contact: Dr. Aron Primack, 301-496-1653, aron_primack@nih.gov; NHLBI Contact: Dr. Cristina Rabadan-Diehl, 301-435-0550, rabadanc@nhlbi.nih.gov.

04-HL-105 Treatment of heart failure with preserved systolic function. Nearly half of all patients with heart failure have preserved left ventricular systolic function, yet still have a poor prognosis. Commonly used strategies for treating such patients include treatment with diuretics, nitrates, angiotensin converting enzyme inhibitors, and/or beta-blockers, but it is not clear how the agents, or combinations of them, compare with one another with respect to their effect on quality and length of life and health care costs. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Michael Lauer, 301-435-0422, lauerm@nhlbi.nih.gov

04-HL-106 Implantable cardioverter defibrillators and cardiac resynchronization therapy in heart failure Implantable cardioverter defibrillators and cardiac resynchronization therapy have been shown to improve clinical outcome in chronic heart failure, but they are expensive technologies and have been studied primarily in the context of carefully managed randomized controlled trials. It is not clear how they compare with standard medical therapy in routine clinical practice and among certain patient subsets, such as women, the elderly, and minorities. Projects that address this challenge could include analyses of existing data registries. Contact: Dr. Michael Lauer, 301-435-0422, lauerm@nhlbi.nih.gov

04-HL-107 Treatment of insomnia. Insomnia is common and is associated with poor quality of life at increased risk for clinical events. Available treatment strategies include sedatives, melatonin, and behavioral interventions. However, it is not clear how they compare with one another with respect to their effect on quality and length of life and health care costs. Projects that answer this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Michael Twery, 301-435-0199, twerym@nhlbi.nih.gov

04-HL-108 Improving clinical outcomes in critically ill patients with respiratory failure. Treatment of critically ill patients involves multiple diverse interventions that affect all organ systems. While many have been viewed as merely supportive and comforting, they may in fact have important effects on outcomes. For example, studies of glucose management and sedation practices have shown reductions in hospital time and even mortality. The evidence base for intensive care medicine is improving in recent years, but many aspects of care are not systematically applied and should be compared and studied. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries Contact: Dr. Andrea Harabin, 301-435-0222, harabina@nhlbi.nih.gov

04-HL-109 Management of sarcoidosis. Sarcoidosis is a systemic granulomatous disease of unknown origin that affects the lungs in about 90 percent of patients. Management is primarily based on the use of corticosteroids, anti-inflammatory agents, and cytotoxic drugs, such as methotrexate. Depending on the organs involved and the severity of disease regimens vary, although sometimes treatment is maintained for prolonged periods, often for many years. It is not clear which regimens and drug combinations and duration of therapy are most effective in controlling the disease, especially lung disease. Regimens for improving or maintaining lung function, other organ function, quality and length of life, and for reducing costs of health care would be of particular interest. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries Contact: Dr. Hannah Peavy, 301-435-0222, peavyh@nhlbi.nih.gov

04-HL-110 Treatment of pulmonary hypertension and right heart failure. Pulmonary hypertension is a devastating, rapidly progressive disease characterized by progressive elevation of pulmonary arterial pressure and pulmonary vascular resistance that leads to right ventricular failure. Current therapies include prostacyclins, phosphodiesterase inhibitors, and endothelin receptor antagonists. The availability of these agents has improved hemodynamic measures and quality of life, but patient response varies significantly, and deterioration in outcomes is not uncommon. Morbidity and mortality remain high, and it is not known how the agents or, particularly, their combinations compare with each other affect outcome and quality of life. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Dorothy Gail, 301-435-0222, gaild@nhlbi.nih.gov

04-HL-111 Personalized algorithms for treatment of COPD. Although many different treatments are efficacious for treating COPD, individuals vary widely in their responsiveness to therapies and few data are available to guide the choice of drug combinations for particular patients. Comparative effectiveness studies are needed to assess both the benefits of combination therapies and to identify individual characteristics that are predictive of treatment responsiveness. Studies that address this challenge area will design and demonstrate feasibility for later studies that will directly test effectiveness of alternative treatment strategies which incorporate substantial stratification of subjects by baseline characteristics, such as biomarkers, genotype, and gene expression profiles. Contact: Dr. Antonello Punturieri, 301-435-0230, punturieria@nhlbi.nih.gov

04-HL-112 Screening for cardiovascular risk factors in children. Cardiovascular risk factors – such as hypertension, elevated cholesterol, and obesity – often begin in childhood. There is substantial evidence that these risk factors in childhood will translate to increased risk of disease later in life. However, there are inconsistent recommendations about the clinical utility of screening children for these risk factors or how broad such screening should be. It is unknown, for example, whether universal screening for high blood cholesterol would be beneficial and cost-effective in youth, or whether it would be harmful and wasteful of clinical resources. Nor is it known whether only some children, and not all, should be screened. Projects that answer this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Denise Simons-Morton, 301-435-0384, simonsd@nhlbi.nih.gov

04-HL-113 Cost-effective trials of CVD prevention in persons with low short-term risk. Traditional clinical trials have provided a powerful evidence base for preventing cardiovascular (CV) events in patients at known high short-term CV risk, but are less suited to addressing the larger problem of preventing or slowing the chronic disease process that creates that risk. Late-stage interventions tend to be resource-intensive, and they come too late for the many persons whose first clinical manifestation of CV disease is a fatal heart attack or stroke. Unfortunately, the duration and sample sizes required for clinical trials employing less intensive interventions in patients whose CV risk lies many years down the road are often prohibitive. The use of modern information technology may provide the means to facilitate more economical large early prevention trials, while preserving patient safety. Projects that answer this challenge could include planning grants for specific large-scale trials comparing strategies of early prevention. Contact: Dr. David Gordon, 301-435-0466, gordond@nhlbi.nih.gov

04-HL-114 Using existing datasets to plan effectiveness trials in pediatric cardiology. Promoting guideline development or comparative effectiveness research in pediatrics is limited by the rarity of diseases, small patient populations, and difficulty (logistical, cost, ethical) in performing randomized, controlled trials. These constraints necessitate creative and novel approaches, such as developing new analytic, statistical, or theoretical strategies for evaluating comparative treatment effects of pediatric medications or interventions. Examples include innovative approaches to evaluating extant data ( e.g., making use of administrative databases, or, increasingly, electronic health records to assess, for example, the comparative effectiveness of different medications administered in the cardiac intensive care unit) or development of novel, computational theoretical models or adaptation of existing procedures (e.g., decision analysis to assess, as an example, the comparative effectiveness of incorporating ECG screening into risk assessment of children receiving stimulant medications). These and similar approaches could be developed and tested using existing data sets in a two-year time frame, and could benefit not only pediatrics, but all research into rare diseases. Contact: Dr. Gail Pearson, 301-435-0510, pearsong@nhlbi.nih.gov

04-HL-115 Treatment of stenosed coronary arteries with hybrid coronary revascularization versus multi-vessel percutaneous intervention with drug eluting stents (DES). The prevalence of coronary artery disease (CAD) is increasing and as a result advances have been made in surgical and percutaneous techniques for revascularization as well as concomitant medical therapy for CAD. The American College of Cardiology Foundation, among other collaborating groups, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The findings indicate that clinical evidence is insufficient for new interventions for three vessel CAD including disease of the Left Anterior Descending Coronary Artery. It is unknown whether hybrid coronary revascularization using a minimally invasive surgical approach with PCI (hybrid procedure) is associated with improved patient outcomes as compared to PCI with DES alone. A randomized, controlled clinical trial targeting a large segment of the CAD population is needed to answer this important public health question. Without scientific evidence, this question will be answered through clinical practice patterns that may not optimize patient outcomes or be cost effective. Projects that answer this challenge could include planning projects for large-scale definitive clinical trials or development of data registries to collect prospective outcomes information on CAD patients receiving different treatments. Contact: Dr. Marissa Miller, 301-594-1542, millerma2@nhlbi.nih.gov

04-HL-116 Cost-effective strategies to achieve smoking cessation in hospitalized patients with cardiovascular disease and COPD. In 2007, 20% of adult Americans were current cigarette smokers, but significant disparities exist by age, race/ethnicity, level of education and socioeconomic status. Smoking is particularly problematic among hospitalized patients; those who continue to smoke after an MI have a 50% higher risk of recurrent coronary events compared to nonsmokers, but the risk for those who quit equals that of nonsmokers after 3 years. Providers are faced with uncertainty regarding optimal and cost-effective strategies to initiate smoking cessation for their hospitalized patients. Options include simple counseling, intensive behavioral interventions, financial incentives, and pharmacotherapy (nicotine replacement, buproprion, and veraclinine). Projects that answer this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Endpoints for comparisons could include safety and effectiveness, quality of life, and cost-effectiveness. Contact: Dr. Jared Jobe, 301-435-0407, jobej@nhlbi.nih.gov

(05) Comparative Effectiveness Research

05-HL-101* Treatment of atrial fibrillation. Atrial fibrillation, the most common acquired arrhythmia in adults, substantially increases risk for stroke and premature death. Percutaneous pulmonary vein ablation and the surgical Cox Maze procedure have been shown to be effective in eliminating arrhythmias, but it is not clear how they compare to standard therapies, such as anticoagulation combined with rate control drugs, with respect to their effect on quality and length of life and health care costs. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Michael Lauer, 301-435-0422, lauerm@nhlbi.nih.gov

05-HL-102* Treatment of obstructive sleep apnea. Obstructive sleep apnea is becoming increasingly common as the nation experiences an obesity epidemic. Patients with obstructive sleep apnea are at increased risk for poor quality of life, myocardial infarction, and stroke. Physicians can treat obstructive sleep apnea with certain medications, surgery, or mechanical devices (continuous positive airway pressure), but it is not clear how the strategies compare with one another with respect to their effect on quality and length of life and health care costs. Projects that answer this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries. Contact: Dr. Michael Twery, 301-435-0199, twerym@nhlbi.nih.gov

05-HL-103* Treatment of mild persistent asthma in children. Physicians currently choose among three alternative approaches to initiate daily, long term therapy for children with asthma that is not well controlled by intermittent therapy alone; namely, low dose inhaled corticosteroids, combination therapy of inhaled corticosteroids and long acting beta-agonists, and leukotriene receptor antagonist. Yet little data are available to inform the physician’s decisions: randomized controlled efficacy trials in children have focused on comparing each drug to placebo rather than directly comparing the three options in children, especially children less than 12 years of age. Large scale, efficient studies are urgently needed to assist physicians in understanding the comparative advantages of the treatments with respect to benefits, risks, and costs. Projects that address this challenge would use existing data bases, e.g., administrative and electronic health records, and distributive data networks to conduct direct comparisons of the three treatments. Contact: Dr. Virginia Taggart, 301-435-0202, taggartv@nhlbi.nih.gov

05-HL-104* Reducing cardiovascular risk in moderate-risk and asymptomatic patients. Evidence-based treatment guidelines exist for patients at high risk for a cardiovascular event due to existing clinical disease or risk factors including hypertension, dyslipidemia, obesity, and smoking. Nearly half of all life-threatening cardiovascular disease events occur in previously asymptomatic people, who may have undetected subclinical disease. In addition, many people are at elevated risk for whom evidence-based treatments are not clear; these include people with moderate elevations of multiple risk conditions as in the Metabolic Syndrome. Various technologies exist to detect asymptomatic subclinical disease and predict risk, including global risk scores, inflammatory biomarkers, specific genotypes, and imaging tests. Many intervention strategies to reduce risk also exist, including lifestyle interventions, various medications, combinations of medications, and combinations of lifestyle and medication. However, it is not clear how the existing technologies compare with each other or could be combined or sequenced, or what intensity of intervention is needed, to reduce disease risk. Projects are needed to address this challenge by comparing effectiveness, risks, and cost-effectiveness of various strategies for screening and treatment of moderate-risk and asymptomatic patients. Projects that address this challenge could include planning projects for large-scale definitive practical trials or sophisticated analyses of existing data registries Contact: Dr. Simons-Morton, 301-435-0384, simonsd@nhlbi.nih.gov

05-HL-105* Optimizing of anti-platelet treatment after revascularization procedures. The long-term effectiveness of revascularization procedures to treat ischemic cardiovascular disease is limited by the risk for thrombotic complications, which may necessitate a second costly procedure, sometimes under emergency conditions, and may even be fatal. Anti-platelet therapy i to offer effective protection against thrombotic complications, though at the cost of increased risk for serious bleeding events, including (potentially fatal) cerebral hemorrhage. Comparative effectiveness trials are needed to determine the best regimens for achieving maximal benefit with minimal risk. Personalized approaches for tailoring the optimal regimen to the particular patient may be of value. Projects that answer this challenge could include planning grants for clinical trials comparing alternative strategies for optimizing anti-platelet therapy in this setting. Contact: Dr. David Gordon, 301-435-0466, gordond@nhlbi.nih.gov

(06) Enabling Technologies

06-HL-101 Develop technologies for assessment of aortic aneurysms prone to rupture or dissection. Thoracic and abdominal aortic aneurysms (TAA and AAA, respectively) are life threatening conditions that together comprise the thirteenth leading cause of death in the U.S. The most common sources of mortality associated with aortic aneurysms are acute dissections (more common to TAA) and rupture (more common to AAA). For both TAAs and AAAs, close monitoring of aneurysm size is the only way currently available to determine when to intervene with elective surgery or endovascular repair to avoid dissection or rupture. However, size is not a reliable predictor so new technologies are needed, such as noninvasive imaging and biomarkers, that can reliably identify aneurysms that are prone to rupture or dissection. Contact: Dr. Eser Tolunay, 301-435-0560, tolunaye@mail.nih.gov

06-HL-102 Develop high affinity/high specificity targeted molecular probes for molecular imaging of cardiovascular and pulmonary disease targets. Clinical imaging currently provides primarily anatomical and functional information that does not address the underlying pathophysiology. Molecular imaging probes have the potential to provide additional information about the disease process itself by interrogating specific targets such as cell surface receptors and enzymes activity. By detecting specific markers expressed in physiological and pathophysiological states, molecular imaging probes can improve detection and staging of disease. The appearance or disappearance of specific probe targets in response to therapy is likely to provide information on therapeutic efficacy much faster than traditional imaging measurements based on anatomical and functional responses, helping to tailor therapies and dosage to individual patients. Contact: Dr. Denis Buxton, 301-435-0513, db225a@nih.gov

06-HL-103 Develop new imaging methodologies to track cells and measure accurately the chemical activities of enzymes and metabolites in intact cells, tissues, and organisms to improve basic understanding of cellular interactions, biological pathways, and their regulation. An improved ability to track cells in vivo will enhance our understanding of homing, engraftment, cell differentiation, and pathogenesis resulting from abnormal cells trafficking. Understanding the components and kinetics involved in biochemical reactions is key to evaluating and predicting the response of intact organisms to physiological and pathophysiological challenges and drug responses. Although our knowledge of the identity and quantity of proteins and complexes associated with reaction pathways in health and disease continues to advance, direct methods for imaging those reactions in intact systems are lacking. Development of appropriate tools to track cells, image the microvasculature, and image chemical activity in intact systems in real time will have broad applicability to many heart diseases, including myocardial ischemia and reperfusion injury, heart failure, and arrhythmias and lung diseases such as COPD, asthma, pulmonary hypertension, and sleep apnea. Similarly, new non-invasive cellular imaging modalities, capable of differentiating between normal and pathological states, would increase our understanding of the role of the microvasculature in sickle cell disease and thrombotic disorders. Contact: Dr. Lisa Schwartz Longacre, 301-402-4826, schwartzlongal@mail.nih.gov

06-HL-104 Develop nanotools for Pulmonary Medicine. Pulmonary nanomedicine tools (mono- or multi-functional) would be of great value for inhalative delivery of encapsulated, controlled released payloads such as pharmaceuticals, gene therapy vectors, and bioactive molecules; detection of subclinical pathology; real-time, in vivo monitoring of injury/repair and treatment effects; and providing a scaffolding for engineered lung tissue. Targeted delivery methods made possible with nanotools should allow safer and more effective administration of life-prolonging drugs such as prostacyclines for pulmonary arterial hypertension, and nanotube-based scaffolds may allow reproduction of the complex microarchitecture required for regeneration of functional lung tissue. Contact: Dr. Robert Smith, 301-435-0202, smithra3@nhlbi.nih.gov

06-HL-105 Develop transgenic animal models that are informative for understanding chronic inflammation in humans. Mouse models offer the advantage of being open to genetic manipulation and can provide data for hypothesis building and pilot intervention studies. Several complex models of inflammation relevant to heart, lung, and blood diseases have been developed, but their effect on the propensity to develop human diseases remains to be determined. Targeted research over short period of time in this area should lead to development of new animal models for chronic inflammation that are relevant to human pathology. Contact: Dr. Andrei Kindzelski, 301-402-0658, kindzelskial@mail.nih.gov

06-HL-106 Ensure a safe and adequate blood supply through the development of new processing technologies. New technologies are needed to eliminate both the infectious and non-infectious complications of blood transfusion and thereby ensure a safe and adequate blood supply. Technologies such as pathogen inactivation/reduction should virtually eliminate transfusion risks from established threats such as HIV and hepatitis and most new or emerging infectious agents including bacterial contaminants. They should also reduce non-infectious complications such as transfusion-related immunomodulation. They and other approaches must be further developed for the treatment of all blood components and research is also needed to determine their safety and efficacy in ameliorating transfusion risks. Contact: Dr. Simone Glynn, 301-435-0078, glynnsa@mail.nih.gov

06-HL-107 Develop new technologies to advance heart, lung, and blood research. The development of new enabling technologies has the potential to significantly enhance diagnostics and therapeutics for heart, lung, and blood diseases. The delivery of drugs and nucleic acid-based therapeutics to disease targets can be significantly enhanced by strategies such as targeting to specific receptors, protection from nucleases and other enzymes, improvement of pharmacokinetics, and directing to the appropriate sub-cellular compartment. The ability to track cell delivery and survival to target tissues would facilitate the optimization of cell-based therapies. Improved surgical tools and procedures for minimally invasive surgery have the potential to decrease patient morbidity and mortality, and improve recovery time and quality of life for surgical patients. The ability to conduct quick and inexpensive assays of environmental risks would greatly enhance investigations of environmental causes of disease. Contact: Dr. Denis Buxton, 301-435-0513, db225a@nih.gov

06-HL-108 Develop new informatics techniques for integrative analysis of genomic and epigenomic data. Much of the complex interplay between genetic and environmental risk factors for disease likely occurs through the interactive regulation of gene expression by both genotype and epigenetic markings of the genome. Epigenetic tags such as cytosine methylation and histone tail modifications, which modulate chromatin structure and function thereby affecting gene expression, are associated with environmental toxicities and are well documented. An integrated analysis of gene expression regulation, with simultaneous consideration of both genetic and epigenetic characteristics and of the interactions between these factors, is essential for understanding the complex pathobiology of chronic heart, lung, and blood diseases. New computational and informatics techniques are needed to allow such analyses. Contact: Dr. Robert Smith, 301-435-0202, smithra3@nhlbi.nih.gov

06-HL-109 Generate reagents for studying lung cell biology and disease progression. Reagents for studying lung cell biology and disease progression are lacking. Examples include antibodies that recognize specific cells types, promoters that are expressed only in certain cell types and can be used in the generation of conditional knockout transgenic animals, and antibodies that recognize cell surface markers and can be used for FACS sorting different cell lineages in the airway. Such markers would be important not only for understanding the heterogeneity of lung cell types but are also for understanding cellular changes in the lung that emerge with lung disease. They may also be useful as surrogates for progression of lung disease and for dissecting cellular heterogeneity/function of lung cell types. Contact: Dr. Herbert Reynolds, 301-435-0222, hr72f@nih.gov

06-HL-110 Develop Lab on a Chip in Kit Form. A sensitive nuclear magnetic resonance setup could easily take up a room. This challenge asks to build a small portable and automated device that can function as NMR by combining the NMR and MRI technology with all the advantages of the microfluidics chip. Such a device would enable the application of a metabolomics approach to many disease areas. Contact: Dr. Weiniu Gan, 301-435-0202, ganw2@nhlbi.nih.gov

06-HL-111       Develop devices and instruments for assessing and supporting assessment of pulmonary function in an ICU. Despite major advances in biotechnology, research and development efforts directed at introducing new and innovative pediatric devices and instruments (of improving the existing ones) for use in critically ill children have been limited. Technologies to assess tissue perfusion, pulmonary function (e.g., gas exchange, airway pressure, lung volumes, ventilation/perfusion ratios, and pulmonary arterial pressures) are needed. Also needing further development are improved systems for respiratory support of children, including non-invasive ventilation and nasal interface for nasal CPAP, improved methods of patient triggered ventilation and synchronization, and improved endotracheal and tracheostomy tubes to decrease nosocomial infection and reduce airleak and airway trauma. Contact: Dr. Carol Blaisdell, 301-435-0219, blaisdellcj@mail.nih.gov

06-OD(OBSSR)-101*    Using new technologies to improve adherence. New and innovative technologies to improve patient adherence to prescribed medical regimens and utilization of adherence-enhancing strategies in clinical practice would greatly enhance the health impact of efficacious treatments and preventive regimens. This challenge invites the development of new technologies to change patient and provider behaviors to improve adherence. OBSSR contact: Lynn Bosco, 301-451-4286, boscol@od.nih.gov; NHLBI Contact: Dr. Susan Czajkowski, 301-435-0406, czajkows@mail.nih.gov ; FIC Contact: Dr. Xingzhu Liu, 301-496-1653, liuxing@mail.nih.gov

(07) Enhancing Clinical Trials

07-OD(OBSSR)-101*     Improving and/or assessing external validity in randomized clinical trials (RCTs). The practice of conducting RCTs with volunteer samples recruited from patients in clinical or community settings limits the generalizability of results, a critical problem for comparative effectiveness research. Research is needed to develop scientific tools for improving and/or assessing the external validity of RCT results to known populations, including methods for applying probability sampling in the identification and recruitment of RCT participants, measuring biases in RCT participant pools, and accounting for such biases in the analysis of RCT results. OBSSR contact: Dr. Ronald Abeles, 301-496-7859, abelesr@od.nih.gov; NHLBI Contact: Dr. Peter Kaufmann, 301-435-2467, kaufmannp@nhlbi.nih.gov

(08) Genomics

08-HL-101*   Identify causal genetic variants associated with heart, lung, and blood diseases by application of targeted DNA capture and massively parallel sequencing technologies followed by selective genotyping of DNA samples from large well-phenotyped populations. Genome-wide association studies (GWAS) have been successful in identifying high frequency genetic variants of modest effect that are associated with numerous common diseases, but identifying actual disease-causing genetic variants will require large-scale DNA sequencing of individuals from well-phenotyped populations. Two applications of this approach are needed: (a) targeted resequencing of entire chromosomal regions already known from GWAS findings to be strongly associated with disease, and (b) disease or other clinical trait-based exome-wide resequencing for the unbiased discovery of rare variants having large effects. Validation/replication of newly discovered genetic variants from both experimental designs would then have to be undertaken by selective genotyping of well-phenotyped populations, particularly from existing large consortia. This sequential strategy is needed to characterize the complete set of causal variants contributing to disease heritability and etiology. Contact: Dr. Alan Michelson, 301-594-5353, michelsonam@nhlbi.nih.gov

08-HL-102 Develop methods to integrate and analyze data from two or more different ‘omics approaches (e.g., GWAS, sequencing, epigenetics, metabolomics, transcriptomics) to capitalize on existing heart, lung, and blood data sets. Considerable resources have been expended in developing ‘omics technologies and applying them to heart, lung, and blood studies. However, the diverse ‘omics technologies each generate multiple data types. Limitations in our ability to combine and analyze data across various ‘omics studies have constrained their use in efforts to elucidate the molecular mechanisms underlying heart, lung, and blood disorders. To obtain full value from those data will require new and improved tools to:

Integrate data across two or more ‘omics data sets.
Analyze integrated data sets using improved statistical tools and approaches necessary to handle the challenges inherent in the complex integrated data sets. Contact: Dr. Deborah Applebaum-Bowden, 301-435-0513, applebad@nhlbi.nih.gov

08-HL-103 Perform Genome-Wide Association and Exon Sequencing Studies for Rare Lung Diseases. Genome-wide association studies (GWAS) have emerged as a powerful tool for identifying genetic variants related to rare diseases such as age-related macular degeneration and Type I diabetes. The emerging all-exon sequencing approach (exome) may also be a useful approach for GWAS of rare diseases. Both GWAS and exome approaches are needed to gain further insight into rare lung diseases. Analysis of well defined clinical phenotypes, especially of the most severe forms of rare lung diseases, should make it possible to reach sufficient statistical power using the existing database and biological samples collections. Case-control, population, cohort, clinical, and family studies for which detailed phenotypic data and DNA samples have already been acquired are all needed. Contact: Dr. Sandra Hatch, 301-435-0222, hatchs@nhlbi.nih.gov

08-HL-104 Assess genetic variation in African Americans and determine its effect on disease. Resources are lacking for imputation of existing SNPs (single nucleotide polymorphisms) or for the assessment of CNVs (copy number variants) and their relation to disease in individuals of African ancestry. Existing statistical software and models involved in SNP imputation should be assessed by examining genotype data for African Americans, creating imputed maps, and genotyping or sequencing the regions of interest that will help to refine both the resulting imputed map and the statistical models used in imputing. Also needed are efforts to identify meaningful CNVs, i.e., CNP (Copy Number Polymorphisms), by accurately measuring copy level, location, and frequencies in established African-American cohort(s). An examination of the association of discovered CNPs between affected and unaffected individuals for a disease measure within a cohort will greatly aid investigators in their understanding of CNVs and their subsequent impact on human disease. Contact: Dr. Paul Sorlie, 301-435-0456, sorliep@nhlbi.nih.gov

08-HL105 Multidisciplinary consortia to stimulate in-depth analysis and gene discovery in existing GWAS. Genome-wide association studies (GWAS) of large population sample sizes have been successful in identifying a number of genetic variants of moderate effect for complex diseases; even larger sample sizes will be needed to discover genes of small effect or to assess gene by gene and gene by environment interactions. To meet this challenge, the NHLBI proposes to support infrastructure and logistics of consortia of over one hundred thousand research participants focused on in-depth analysis and data mining coupled with highly focused follow-up genotyping and resequencing in specific domains (e.g., cardiovascular, pulmonary, sleep, blood disease, obesity, metabolic syndrome). Consortia would have expertise in phenotyping, genotyping, sequencing and analysis, would leverage our investment in GWAS and maximize scientific output from shared data sets. Contact: Dr. Paul Sorlie, 301-435-0456, sorliep@nhlbi.nih.gov

01-OD(OBSSR)-102*    Methods for studying the interactions among behaviors, environments, and genetic/epigenetic processes. Research is needed to develop analytic methods, systems science approaches, or computational models designed to address the interactions among individual behaviors, social and physical environments and genetic/epigenetic processes during critical developmental periods and over time. This research is essential to incorporating the dynamic complexity of behavior and environments in the study of gene-environment interactions in health. OBSSR contact: Kay Wanke, 301-435-3718, wankek@od.nih.gov; NHLBI Contact: Dr. Peter Kaufmann, 301-435-2467, kaufmannp@nhlbi.nih.gov

(09) Health Disparities

09-HL-101     Develop tools to detect early indicators of health disparities, and to test collaborative interventions to reduce differential health care or outcomes for heart, lung, and blood diseases. The purpose of this challenge is twofold: first, to develop new measures of early determinants of disparities; and second, to develop and test interventions to reduce health and healthcare disparities. Multidisciplinary research studies across entities such as healthcare, education, and housing to improve built environment, neighborhood structures, and health education, for example, would create unique opportunities to mitigate differences in health outcomes at the population level. The focus of both should be on the patient, social and community context as well as the healthcare setting and provider characteristics. Contact: Dr. Lawrence Fine, 301-435-0305, lf128x@nih.gov

(10) Information Technology for Processing Health Care Data for Research

10-HL-101*   Develop data sharing and analytic approaches to obtain from large-scale observational data, especially those derived from electronic health records, reliable estimates of comparative treatment effects and outcomes of cardiovascular, lung, and blood diseases . Advances in this area will address two important barriers to research on comparative treatment effects:

inability to link data across disparate data platforms and health care settings
inability to address confounding and on-treatment biases in observational studies based on data from clinical practice.

The first could be addressed by creating an interoperable electronic health record (EHR)-based research platform that assures privacy and confidentiality while allowing questions to be addressed that could not be by using data from only one clinical practice, health plan, or health system; the second by developing new methods to address confounding when attempting to use observational data to compare treatment effects, e.g., instrumental variables, innovative quasi-experimental designs, facilitating ecologic analyses of clinical data using linkages of geographic and clinical data. Such approaches would increase the credibility and value of observational analyses of huge integrated EHR databases in identifying optimal treatment practices for cardiovascular, lung, and blood diseases with multiple available treatment options. Contact: Dr. Michael Lauer, 301-435-0422, ml580m@nih.gov

(11) Regenerative Medicine

11-HL-101* Develop cell-based therapies for cardiovascular, lung, and blood diseases. Cell-based therapies for cardiovascular, lung, and blood diseases offer a new paradigm for advancing and transforming patient care. Translational and early-phase clinical research has demonstrated that cell-based therapies may improve left ventricular function, reduce myocardial ischemia, and lead to improved lung function. Reconstitution of normal hematopoeisis using modified stem cell graft sources has great potential for treating specific genetic blood disorders. However, a number of significant challenges and barriers must be overcome to move the field forward toward broad clinical application. We encourage further research to determine the characteristics of the most promising target patient population, the best cell type and number of cells to use, the optimal methods and timing of delivery, and other preclinical parameters. Contact: Dr. Sonia Skarlatos, 301-435-0477, skarlats@nhlbi.nih.gov

(12) Science, Technology, Engineering and Mathematics (STEM) Education

For this RFA, there is no NHLBI-specific Challenge Topic in this Challenge Area.

(13) Smart Biomaterials - Theranostics

For this RFA, there is no NHLBI-specific Challenge Topic in this Challenge Area.

(14) Stem Cells

14-HL-101* Develop molecular signatures for heart, vascular, lung, and blood diseases by profiling reprogrammed induced pluripotent stem cells derived from affected individuals of defined genotype. Large-scale profiling of RNA, proteins, and metabolites derived from normal and disease tissues has been instrumental in identifying the molecular etiologies of numerous disorders, but the applicability of this approach has been limited by the availability of relevant biological materials. Cell-based models of disease generated from stem cell technologies could be readily profiled with available high-throughput methods. Such studies could be undertaken on small numbers of control and affected individuals or on a larger population that would more broadly sample human genetic variation and thereby allow statistical associations to be established among genotypes, clinical traits, and molecular signatures that may elucidate causal mechanisms underlying complex diseases. Contact: Dr. Alan Michelson, 301-594-5353, michelsonam@nhlbi.nih.gov

14-HL-102 Bio-models and scaffolds for blood cell production and tissue regeneration. Stem cells have the potential to serve as a virtually unlimited source of all blood cell lineages for use in transfusion medicine, other cellular therapies, and tissue regeneration. Generation of blood cells of the required lineages and in the required numbers, and tissue regeneration uses spatial cues and tissue topography not reproduced in simple cell culture systems. Advances in stem cell technology and blood cell signaling networks have led us to the point that new bio-models and scaffolds can be developed to regenerate tissues and increase blood cell production to levels needed for clinical applications. Contact: Dr. John Thomas, 301-435-0065, thomasj@nhlbi.nih.gov

(15) Translational Science

15-HL-101 Develop improved biocompatible surfaces for implantable blood-contacting medical devices. Implantable blood-contacting medical devices such as stents, prosthetic heart valves, vascular grafts, and circulatory support devices, are widely employed therapies that have benefited many people. They are also, however, often a site for thrombosis, inflammation, and infection. Improved biocompatible surfaces for such devices could reduce thrombosis, inflammation, and infection and thereby significantly reduce patient morbidity and mortality. Contact: Dr. Martha Lundberg, 301-435-0513, lundbergm@nhlbi.nih.gov

15-HL-102 Develop new therapeutic strategies for heart, lung, and blood diseases based on microRNA technology. MicroRNAs (miRNA) are involved in regulating gene expression at the post-transcriptional level. About 500 human miRNAs have been discovered. Initial evidence suggests that they play significant roles in endothelial cell migration, proliferation, vascular and airway inflammation and fibrosis and remodeling, and in the airway response to cigarette smoking, all of which are key mechanisms in atherosclerosis and thrombosis and chronic lung disease. Research is needed to improve our understanding of the miRNA network and its function related to heart, lung and blood diseases and to develop new targets and therapeutic strategies including gene therapy based on MiRNA technology to treat them. Contact: Dr. Pothur Srinivas, 301-435-0550, srinivap@nhlbi.nih.gov

15-HL-103 Establish the infrastructure to obtain, in a standardized manner, diseased and healthy human cardiac tissue obtained at surgery for immediate electromechanical studies to further the fundamental understanding of cardiac rhythm and contractility. Most deaths among patients with CAD are due to ventricular fibrillation and other tachyarrhythmias. Contemporary approaches to prevent sudden cardiac arrest and subsequent deaths SCA/D continue to be limited. Although implantable cardioverter defibrillators (ICDs) in primary prevention of SCA/D are life-saving, as currently applied they are also inefficient and costly. Traditional antiarrhythmic drugs have not reduced mortality and in some cases, are proarrhythmic. Failed pharmacotherapy may be due to the gathering of preclinical data from inappropriate animal models, and to the clinical dissociation between prevention of premature ventricular depolarizations and SCA/D. Fundamental electromechanical studies of living human cardiac tissues will fill the gaps left by animal studies and lead to optimal diagnosis, treatment, and prevention of potentially fatal arrhythmias. Contact: Dr. Dennis Przywara, 301-435-0506, przywarad@nhlbi.nih.gov

15-HL-104 Characterize the role and effects of the respiratory and/or intestinal microbiota on the presence and clinical phenotype of lung disease. The development and progression of lung diseases are strongly influenced by the behavior of immunological defense mechanisms in the airways, and a major contributor to individual immune phenotypes is the microorganisms that establish themselves in a person immediately after birth and subsequently throughout life. Very little is known about the respiratory tract microbiome or the relationship of lung disease to microbes in the respiratory tract or in other parts of the body, particularly the gut. Investigations of the relationships between individual microbiomes and lung diseases will not only provide important insights into the causes and mechanisms of lung diseases such as asthma, COPD, and pulmonary fibrosis but also offer great potential for rapid translation of research results into improved approaches for lung disease prevention and treatment. Contact: Dr. Hannah Peavy, 301-435-0222, peavyh@nhllbi.nih.gov

15-HL-105 Employ metabolomic approaches to Improve diagnose, stage, and select therapies for lung diseases. Because of the great cellular diversity and environmental exposure of the lung, pulmonary diseases are often highly complex, involving many molecular pathways, varied clinical manifestations, and multiple therapeutic targets. Single chemical, laboratory, or physiological measures are often inadequate for properly characterizing the presence, severity, and phenotype of lung disease. Metabolomic analyses are of particular interest for lung diseases because they may capture the behavior of the pulmonary system as a whole. Metabolomic analyses of exhaled breath, sputum, blood, and/or urine offer great promise for characterization of patients with complex pulmonary conditions; and exploratory studies of metabolomic profiles in lung diseases will likely yield discoveries that are of great importance for early diagnosis, clinical phenotyping, and therapeutic stratification of lung diseases. Contact: Dr. Weiniu Gan, 301-435-0202, ganw2@nhlbi.nih.gov

15-TW-101 Models to predict health effects of climate change. Quantitative and predictive models of effects of climate change on disease burden and health outcomes are needed. Approaches may include statistical, spatial or other modeling methods to quantify the current impacts of climate on a diversity of communicable or non-communicable diseases, or project impacts of different climate and socio-economic scenarios on health. For example, new and innovative approaches to develop projections of changes in disease burden in specific regions or populations will facilitate public health planning. Existing databases on population and environmental variables, such as air quality and climatologic episodes should be used to test the utility of these models where possible. Contact: Dr. Joshua Rosenthal, 301-496-1653, joshua_rosenthal@nih.gov; NHLBI Contact: Dr. Lawrence Fine, 301-435-0305, finel@nhlbi.nih.gov

For general information on NHLBI’s implementation of NIH Challenge Grants, contact:

CARL ROTH, Ph.D., LL.M.
Associate Director for Scientific Program Operation
National Heart, Lung, and Blood Institute
National Institutes of Health
301-496-6331
rothc@nhlbi.nih.gov

For Financial or Grants Management questions, contact:

RYAN LOMBARDI
Office of Grants Management
National Heart, Lung, and Blood Institute
National Institutes of Health
301-435-0182
lombardr@nhlbi.nih.gov

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