Heart Failure Clinical Trial

Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

894

Study ID:

NCT01685840

Recruitment Status:

Terminated

Sponsor:

Duke University

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There are 46 Locations for this study

See Locations Near You

The Heart Center PC
Huntsville Alabama, 35801, United States
Sutter Memorial Hospital
Sacramento California, 95819, United States
University of California San Diego Medical Center
San Diego California, 92037, United States
Yale University School of Medicine
New Haven Connecticut, 06510, United States
Holy Cross Medical Group
Coral Springs Florida, 33065, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Emory University
Atlanta Georgia, 30322, United States
University Cardiology Associates, LLC
Augusta Georgia, 30901, United States
Fox Valley Clinical Research Center, LLC
Aurora Illinois, 60504, United States
Krannert Institute of Cardiology
Indianapolis Indiana, 46202, United States
University of Maryland
Baltimore Maryland, 21201, United States
Metropolitan Cardiovascular Consultants
Beltsville Maryland, 20705, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Medical Center
Boston Massachusetts, 02215, United States
Pentucket Medical Associates
Haverhill Massachusetts, 01830, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
San Luis Missouri, 63112, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cardiovascular Associates of the Delaware Valley
Cherry Hill New Jersey, 08034, United States
Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
Cardiovascular Associates of the Delaware Valley
Sewell New Jersey, 08080, United States
Bronx-Lebanon Hospital Center
Bronx New York, 10457, United States
Jacobi Medical Center
Bronx New York, 10461, United States
Albert Einstein University Hospital
Bronx New York, 10467, United States
New York Methodist Hospital
Brooklyn New York, 11215, United States
Saratoga Cardiology Associates
Saratoga Springs New York, 12866, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Novant Health Heart and Vascular Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
LeBauer Cardiovascular Research Foundation
Greensboro North Carolina, 27401, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Capitol Area Research, LLC
Camp Hill Pennsylvania, 17011, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Allegheny-Singer Research Institute
Pittsburg Pennsylvania, 15212, United States
AnMed Health Medical Center
Anderson South Carolina, 29621, United States
University of Texas Southwestern Medical Center Dallas
Dallas Texas, 75390, United States
Intermountain Medical Center
Murray Utah, 84157, United States
Cardiovascular Associates, Ltd.
Chesapeake Virginia, 23320, United States
Foothills Medical Centre
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Saint Paul's Hospital
Vancouver British Columbia, V6Z 1, Canada
Hamilton Health Sciences
Hamilton Ontario, L8L 2, Canada
St. Michaels Hospital
Toronto Ontario, M5B 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

894

Study ID:

NCT01685840

Recruitment Status:

Terminated

Sponsor:


Duke University

How clear is this clinincal trial information?

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