Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

Who is eligible to participate?

Inclusion Criteria: - Age 18 years or older - Hospitalization for acute decompensated HF, manifest by Dyspnea at rest or on minimal exertion plus At least 1 sign of volume overload: - Elevated jugular venous pulse - Pulmonary rates - Peripheral edema - Congestion on chest x-ray - Most recent documented LVEF to be ≤ 40% by any method within 12 months of randomization. This assessment must occur at least 12 weeks after any intervention likely to improve ejection fraction (e.g., cardiac resynchronization therapy, initiation of beta-blocker therapy, or revascularization). - NT-ProBNP > 2000 pg/mL at least once during index hospitalization - Willing to provide informed consent Exclusion Criteria: - Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days - Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device - Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy - Severe stenotic valvular disease - Anticipated heart transplantation or ventricular assist device within 12 months - Chronic inotropic therapy - Complex congenital heart disease - End stage renal disease with renal replacement therapy - Non cardiac terminal illness with expected survival less than 12 months - Women who are pregnant or planning to become pregnant - Inability to comply with planned study procedures - Enrollment or planned enrollment in another clinical trial

Last updated:
10/16/2013
NCT ID:
NCT01685840
IRB Number:
13-002314