Heart Failure Clinical Trial
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Summary
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
High risk heart failure as defined by the following criteria:
A Heart Failure Event in the prior 12 months, defined as any one of the following:
HF Hospitalization
Treatment in the Emergency Department (or equivalent) for Heart Failure
Outpatient treatment for heart failure with intravenous diuretics
AND
NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
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
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There are 46 Locations for this study
Huntsville Alabama, 35801, United States
Sacramento California, 95819, United States
San Diego California, 92037, United States
New Haven Connecticut, 06510, United States
Coral Springs Florida, 33065, United States
Fort Lauderdale Florida, 33308, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30901, United States
Aurora Illinois, 60504, United States
Indianapolis Indiana, 46202, United States
Baltimore Maryland, 21201, United States
Beltsville Maryland, 20705, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Haverhill Massachusetts, 01830, United States
Rochester Minnesota, 55905, United States
San Luis Missouri, 63112, United States
Lebanon New Hampshire, 03756, United States
Cherry Hill New Jersey, 08034, United States
New Brunswick New Jersey, 08903, United States
Sewell New Jersey, 08080, United States
Bronx New York, 10457, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Brooklyn New York, 11215, United States
Saratoga Springs New York, 12866, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27401, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Camp Hill Pennsylvania, 17011, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburg Pennsylvania, 15212, United States
Anderson South Carolina, 29621, United States
Dallas Texas, 75390, United States
Murray Utah, 84157, United States
Chesapeake Virginia, 23320, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 1, Canada
Vancouver British Columbia, V6Z 1, Canada
Hamilton Ontario, L8L 2, Canada
Toronto Ontario, M5B 1, Canada
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