Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

Not Applicable

Terminated

• Conditions: Heart Failure

• 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.

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2012-12
• Primary Completion: 2016-09-20
• Study Completion: 2016-09-20
• Results First Submitted: 2017-09-20
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-10
• Last Update Submitted: 2017-11-10
• Results First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 894

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

The Heart Center PC; 🇺🇸 Huntsville, Alabama, United States

Sutter Memorial Hospital; 🇺🇸 Sacramento, California, United States

University of California San Diego Medical Center; 🇺🇸 San Diego, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Holy Cross Medical Group; 🇺🇸 Coral Springs, Florida, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University Cardiology Associates, LLC; 🇺🇸 Augusta, Georgia, United States

Fox Valley Clinical Research Center, LLC; 🇺🇸 Aurora, Illinois, United States

Krannert Institute of Cardiology; 🇺🇸 Indianapolis, Indiana, United States

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