Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

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

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.

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.

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