Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01685840

Run by

Duke University

People needed

894

Starts

2012-12-01

Expected to finish

2016-09-20

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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