Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure
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
Sites / Locations
- The Heart Center PC
- Sutter Memorial Hospital
- University of California San Diego Medical Center
- Yale University School of Medicine
- Holy Cross Medical Group
- Holy Cross Hospital
- Emory University
- University Cardiology Associates, LLC
- Fox Valley Clinical Research Center, LLC
- Krannert Institute of Cardiology
- University of Maryland
- Metropolitan Cardiovascular Consultants
- Massachusetts General Hospital
- Beth Israel Medical Center
- Pentucket Medical Associates
- Mayo Clinic
- Washington University School of Medicine
- Dartmouth Hitchcock Medical Center
- Cardiovascular Associates of the Delaware Valley
- Robert Wood Johnson University Hospital
- Cardiovascular Associates of the Delaware Valley
- Bronx-Lebanon Hospital Center
- Jacobi Medical Center
- Albert Einstein University Hospital
- New York Methodist Hospital
- Saratoga Cardiology Associates
- University of North Carolina at Chapel Hill
- Novant Health Heart and Vascular Institute
- Duke University Medical Center
- LeBauer Cardiovascular Research Foundation
- University of Cincinnati Medical Center
- Cleveland Clinic Foundation
- Capitol Area Research, LLC
- Drexel University College of Medicine
- Thomas Jefferson University Hospital
- Allegheny-Singer Research Institute
- AnMed Health Medical Center
- University of Texas Southwestern Medical Center Dallas
- Intermountain Medical Center
- Cardiovascular Associates, Ltd.
- Foothills Medical Centre
- University of Alberta Hospital
- Vancouver General Hospital
- Saint Paul's Hospital
- Hamilton Health Sciences
- St. Michaels Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Usual Care
Biomarker-Guided 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.
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.