Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

NCT ID: NCT01685840

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 894 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-09-20

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

Usual Care

Biomarker-Guided 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.

Group Type: EXPERIMENTAL

Biomarker-guided care NT-proBNP

Intervention Type: DEVICE

Device: NT-proBNP

Interventions

Usual Care

Usual Care

Intervention Type: OTHER

Biomarker-guided care NT-proBNP

Device: NT-proBNP

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Felker, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

University of Maryland

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants

Beltsville, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Medical Center

Boston, Massachusetts, United States

Pentucket Medical Associates

Haverhill, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cardiovascular Associates of the Delaware Valley

Cherry Hill, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, United States

New York Methodist Hospital

Brooklyn, New York, United States

Saratoga Cardiology Associates

Saratoga Springs, New York, United States

Bronx-Lebanon Hospital Center

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Albert Einstein University Hospital

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Capitol Area Research, LLC

Camp Hill, Pennsylvania, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, United States

AnMed Health Medical Center

Anderson, South Carolina, United States

University of Texas Southwestern Medical Center Dallas

Dallas, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Cardiovascular Associates, Ltd.

Chesapeake, Virginia, United States

Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Saint Paul's Hospital

Vancouver, British Columbia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Michaels Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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Other Identifiers

Pro00033097

Identifier Type: -

Identifier Source: org_study_id