This trial is active, not recruiting.

Condition heart failure
Treatments usual care, biomarker-guided care nt-probnp
Sponsor Duke University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date December 2012
End date October 2016
Trial size 1100 participants
Trial identifier NCT01685840, Pro00033097


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
usual care
Usual Care
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
biomarker-guided care nt-probnp
Device: NT-proBNP

Primary Outcomes

Time to CV death or HF Hospitalization
time frame: 12 months

Secondary Outcomes

Time to All-cause mortality
time frame: 12 months
Cumulative Morbidity
time frame: 12 months
Time to Death
time frame: 12 months
Time to first HF hospitalization
time frame: 12 months
Health Related Quality of Life
time frame: 12 months
Resource Utilization, cost and cost effectiveness
time frame: 12 months
Number of participants with AEs of interest and/ or SAEs
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Principal investigator Michael Felker, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.