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Sponsors and Collaborators: |
Massachusetts General Hospital Hoffmann-La Roche |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00351390 |
Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.
It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.
The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Other: Drug therapy for HF Other: NT-proBNP guided HF therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study |
Estimated Enrollment: | 300 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SOC: Placebo Comparator
Standard of care HF therapy without NT-proBNP guidance
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Other: Drug therapy for HF
Titration of HF meds in an aggressive out patient manner
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NT-proBNP arm: Active Comparator
NT-proBNP plus standard HF management
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Other: NT-proBNP guided HF therapy
drug therapy titrated to achieve NT-proBNP <1000 pg/mL
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300 patients with class II-IV heart failure (HF) due to systolic dysfunction (left ventricular ejection fraction <40%) and recent (within 6 months) destabilized HF will be randomized 1:1 to either 'standard of care' therapy for their HF versus 'standard of care plus NT-proBNP guided' care.
At randomization, patients at MGH will undergo a 2-dimensional echocardiogram for cardiac structure and function.
Patients randomized to the 'standard of care' arm of the study will receive aggressive therapy for their HF, including evidence-based addition/titration of therapeutic agents in the trial, such as carvedilol or metoprolol XL, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, spironolactone inhibitors (for those in class III or IV), digoxin (when applicable), loop diuretics, as well as nitrates with or without hydralazine. Biventricular pacing with/without ICD capability will be performed at the discretion of the investigator. Any changes in therapy will be accompanied by a 2 week follow up for re-assessment and further titration of medications, based on clinical judgment.
At each interim visit, patients in the 'standard of care' arm will have a Minnesota Living with Heart Failure questionnaire taken. For all visits, including those triggered by med changes, laboratories will be checked including serum chemistries; a sample of blood for blinded NT-proBNP, troponin T, and high sensitivity CRP will be obtained for measurement after the trial is complete.
Patients randomized to the 'standard of care plus NT-proBNP guided' arm will receive the same aggressive medical care as above, but will also have an unblinded measurement of NT-proBNP provided to the study investigator within an hour of first patient contact. Therapeutic decision-making will be first based on clinical acumen/judgment, but if the NT-proBNP is elevated, per protocol, the investigator will adjust therapies accordingly, including escalation of existing therapies with known effects on NT-proBNP levels, as well as possible addition of similar therapies not yet in use (such as spironolactone).
Patients will be followed for events including destabilized HF (in or outpatient), cardiovascular events (including ischemic complications, ICD discharge, or development of non-fatal arrhythmia such as atrial fibrillation), or death.
At the end of one year, event rates will be assessed and the outcomes in the two arms will be compared. As well, echocardiography will be performed on subjects at one year and differences from baseline in both groups will be assessed.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James L Januzzi, MD, FACC | 617-726-3443 | jjanuzzi@partners.org |
Contact: Linda Barajas, RN | 617-726-0183 | lbarajas@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02467 | |
Contact: James L. Januzzi, MD, FACC 617-726-3443 jjanuzzi@partners.org | |
Contact: Linda Barajas, RN 617-726-0183 lbarajas@partners.org | |
Sub-Investigator: G. William Dec, MD | |
Sub-Investigator: Marc Semigran, MD | |
Sub-Investigator: Stephanie Moore, MD | |
Sub-Investigator: Dorothy Noyes, ANP | |
Sub-Investigator: Gregory Lewis, MD | |
Sub-Investigator: Christopher Newton-Cheh, MD | |
Sub-Investigator: Abelardo Martinez, MD | |
Sub-Investigator: Sandy Green, MD | |
Sub-Investigator: Kent B Lewandrowski, MD | |
Sub-Investigator: Patrick M Sluss, PhD | |
Sub-Investigator: Elizabeth Lee-Lewandrowski, PhD, MPH | |
Principal Investigator: James L. Januzzi, MD, FACC |
Principal Investigator: | James L. Januzzi, MD, FACC | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( James L. Januzzi MD ) |
Study ID Numbers: | 2004-P-001447/12 |
Study First Received: | July 10, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00351390 |
Health Authority: | United States: Institutional Review Board |
congestive heart failure treatment congestive heart failure, prognosis NT-proBNP testing |
Natriuretic Peptide, Brain Heart Failure Heart Diseases |
Cardiovascular Diseases |