Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Duke University
- Enrollment
- 894
- Locations
- 45
- Primary Endpoint
- CV Death or Heart Failure Hospitalization
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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
- •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
Outcomes
Primary Outcomes
CV Death or Heart Failure Hospitalization
Time Frame: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Secondary Outcomes
- Percentage of Patients With Moderate to Severe Depression(Baseline, 3,6, 12 and 24 months)
- Duke Activity Status Index (DASI)(Baseline, 3, 6, 12 and 24 months)
- EQ-5D Health Index(Baseline, 3, 6, 12 and 24 months)
- EQ-5D Visual Analog Scale(Baseline, 3, 6, 12 and 24 months)
- All-cause Mortality(24 months)
- Cumulative Morbidity(24 months)
- CV Death(24 months)
- Number of Hospitalizations for First Heart Failure(24 months)
- Number of Hospitalizations for Recurrent Heart Failure(24 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score(Baseline, 3, 6,12 and 24 months)
- Short Form-36 (SF-36) General Health Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Mental Health Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Social Functioning Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Physiological Functioning Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Vitality Subscale(Baseline, 3, 6, 12 and 24 months)
- Resource Utilization(24 months)
- Resource Utilization Cost(24 months)