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Sponsored by: |
Georgetown University |
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Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00377949 |
The purpose of this study is to determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization. Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT symptoms.
Condition |
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Systemic Sclerosis Scleroderma Pulmonary Hypertension Pulmonary Arterial Hypertension |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | The Natural History and Outcome of Patients With Scleroderma at High Risk for or With Early Pulmonary Hypertension |
Estimated Enrollment: | 400 |
Study Start Date: | February 2005 |
Systemic sclerosis (SSc) is a rare, often fatal idiopathic disease, which has no effective therapy. One of the most major complications of systematic sclerosis is pulmonary hypertension (PHT), which is now the cause of all scleroderma related deaths. New therapeutic advances have improved short-term management of pulmonary hypertension in scleroderma, but long-term outcomes are unknown. With this in mind, Dr. Steen has developed Pulmonary Hypertension Assessment Registry of Scleroderma (PHAROS), a preventive, multi-center, web based observational study that looks at the natural history and outcome of scleroderma patients who are at high risk or have early pulmonary hypertension. Patients entered into the registry will be followed in prospective fashion noting the clinical course of disease by both scheduled and event driven follow up. A thorough baseline history will be collected to determine key prognostic and correlative factors for both disease prevalence and progression. Yearly follow up consisting of questionnaires, pulmonary function tests, echocardiogram, 6 minute walk tests and predefined patient characteristics will also be conducted to further understand and note the progression of scleroderma related PAH. Event driven follow up will occur to record findings and record specific predetermined events in the clinical course of disease.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary care, rheumatology and pulmonary hypertension clinics.
Global Inclusion Criteria
Eligible patients must meet all of the following inclusion criteria:
Inclusion Criteria
Exclusion Criteria:
Contact: Aida Manu | 202-687-6318 | amanu@georgetown.edu |
Contact: Catherine Ford | 202-687-6317 | cf283@georgetown.edu |
United States, California | |
UCLA Medical Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Amber Betchel 310-825-0425 abetchel@mednet.ucla.edu | |
Principal Investigator: Daniel Furst, MD | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Louise McManus 650-493-5000 ext 64571 louise.mcmanus@va.gov | |
Principal Investigator: Lorinda Chung, MD | |
United States, Colorado | |
National Jewish Medical and Research Center | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Shontel Sarmiento SarmientoS@njc.org | |
Principal Investigator: Aryeh Fischer, MD | |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Aida Manu 202-687-6318 anm42@georgetown.edu | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Anabel Garza 312-503-0377 a-garza@northwestern.edu | |
Principal Investigator: Monique Hinchcliff, MD | |
United States, Maryland | |
John Hopkins University Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Adrienne Woods 410-550-6820 awoods9@jhmi.edu | |
Sub-Investigator: Laura Hummers, MD | |
Principal Investigator: Fred Wigley, MD | |
United States, Massachusetts | |
Boston University Medical School | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Kim Finch 617-638-7503 kimtobin@bu.edu | |
Principal Investigator: Robert Simms, MD | |
University of Massachussetts Memorial Medical Center | Recruiting |
Worcester, Massachusetts, United States, 01605 | |
Contact: Firas Alkassab, MD AlkassaF@ummhc.org | |
Principal Investigator: Firas Alkassab, MD | |
United States, Michigan | |
University of Michigan-Scleroderma Program | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Ann Impens 734-936-1439 aimpens@med.umich.edu | |
Contact: Matthew Shankin 734-232-2090 shankinm@med.umich.edu | |
Principal Investigator: James Seibold, MD | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Valerie Ferment 612-624-9038 ferm0016@umn.edu | |
Principal Investigator: Barbara Segal, MD | |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Julianne Wilson 732-418-8483 wilsonj6@umdnj.edu | |
Principal Investigator: Vivien Hsu, MD | |
United States, New York | |
Center for Rheumatology | Recruiting |
Albany, New York, United States, 12206 | |
Contact: Justine Feder-Lailer 518-533-1349 jfeder-lailer@joint-docs.com | |
Principal Investigator: Lee Shapiro, MD | |
North Shore Long Island Jewish Medical Center | Recruiting |
New Hyde Park, New York, United States, 11040 | |
Contact: Michelle Kong 516-708-2557 MKong@NSHS.edu | |
Principal Investigator: Avram Goldberg, MD | |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Chris Derk, MD chris.derk@jefferson.edu | |
Principal Investigator: Chris Derk, MD | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15261 | |
Contact: Robyn Domsic, MD rtd4@pitt.edu | |
Principal Investigator: Thomas Medsger, MD | |
Sub-Investigator: Robyn Domsic, MD | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Donna Jordan 843-792-5290 jordands@musc.edu | |
Principal Investigator: Marcy Bolster, MD | |
United States, Texas | |
The University of Texas Health Science Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Marcia Kerr 713-500-7118 Marcia.L.Kerr@uth.tmc.edu | |
Principal Investigator: Maureen D Mayes, MD | |
United States, Wisconsin | |
The Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Mary E Csuka, MD mecsuka@mcw.edu | |
Principal Investigator: Mary E Csuka, MD |
Principal Investigator: | Virginia D. Steen, MD | Georgetown University |
Responsible Party: | Georgetown University ( Virginia Steen, MD ) |
Study ID Numbers: | IRB # 04-227 |
Study First Received: | September 18, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00377949 |
Health Authority: | United States: Institutional Review Board |
Systemic Sclerosis Scleroderma Pulmonary Hypertension PHAROS PHROS |
Exercise Echocardiogram Pulmonary Functional Tests Six minute walk tests 6 minute walk tests Right heart catheterization |
Idiopathic pulmonary hypertension Skin Diseases Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Vascular Diseases |
Connective Tissue Diseases Sclerosis Scleroderma, Systemic Scleroderma, Localized Hypertension |
Pathologic Processes Cardiovascular Diseases |