Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
- Conditions
- Heart Failure
- Interventions
- Device: Biomarker-guided care NT-proBNPOther: Usual Care
- Registration Number
- NCT01685840
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 894
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biomarker-Guided Care Biomarker-guided care NT-proBNP 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. Usual Care Usual Care 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.
- Primary Outcome Measures
Name Time Method CV Death or Heart Failure Hospitalization 24 Months Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Moderate to Severe Depression Baseline, 3,6, 12 and 24 months Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D).
CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.Duke Activity Status Index (DASI) Baseline, 3, 6, 12 and 24 months The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
EQ-5D Health Index Baseline, 3, 6, 12 and 24 months The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
EQ-5D Visual Analog Scale Baseline, 3, 6, 12 and 24 months The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
All-cause Mortality 24 months All-cause mortality by treatment arm
Cumulative Morbidity 24 months Days alive and not hospitalized for CV reasons
CV Death 24 months CV death by treatment arm
Number of Hospitalizations for First Heart Failure 24 months First Heart Failure Hospitalization
Number of Hospitalizations for Recurrent Heart Failure 24 months Recurrent Heart Failure Hospitalization
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Baseline, 3, 6,12 and 24 months This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Short Form-36 (SF-36) General Health Subscale Baseline, 3, 6, 12 and 24 months SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Mental Health Subscale Baseline, 3, 6, 12 and 24 months SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Social Functioning Subscale Baseline, 3, 6, 12 and 24 months SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Physiological Functioning Subscale Baseline, 3, 6, 12 and 24 months SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Vitality Subscale Baseline, 3, 6, 12 and 24 months SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Resource Utilization 24 months Observed Resource Use
Resource Utilization Cost 24 months Observed Hospital-Based Cost.
Trial Locations
- Locations (45)
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
University of Texas Southwestern Medical Center Dallas
🇺🇸Dallas, Texas, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Krannert Institute of Cardiology
🇺🇸Indianapolis, Indiana, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Saint Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Beth Israel Medical Center
🇺🇸Boston, Massachusetts, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Metropolitan Cardiovascular Consultants
🇺🇸Beltsville, Maryland, United States
Albert Einstein University Hospital
🇺🇸Bronx, New York, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Pentucket Medical Associates
🇺🇸Haverhill, Massachusetts, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Sewell, New Jersey, United States
Washington University School of Medicine
🇺🇸San Luis, Missouri, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Bronx-Lebanon Hospital Center
🇺🇸Bronx, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Cardiovascular Associates, Ltd.
🇺🇸Chesapeake, Virginia, United States
St. Michaels Hospital
🇨🇦Toronto, Ontario, Canada
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Saratoga Cardiology Associates
🇺🇸Saratoga Springs, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
The Heart Center PC
🇺🇸Huntsville, Alabama, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University Cardiology Associates, LLC
🇺🇸Augusta, Georgia, United States
Holy Cross Medical Group
🇺🇸Coral Springs, Florida, United States
Fox Valley Clinical Research Center, LLC
🇺🇸Aurora, Illinois, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburg, Pennsylvania, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Capitol Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States