Clinical trial NCT01685840: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Official title: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-09-14
Enrollment: 894
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CV Death or Heart Failure Hospitalization
timeFrame: 24 Months
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 24 months
measure: Cumulative Morbidity
timeFrame: 24 months
measure: CV Death
timeFrame: 24 months
measure: Number of Hospitalizations for First Heart Failure
timeFrame: 24 months
measure: Number of Hospitalizations for Recurrent Heart Failure
timeFrame: 24 months
measure: Percentage of Patients With Moderate to Severe Depression
timeFrame: Baseline, 3,6, 12 and 24 months
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: EQ-5D Health Index
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: EQ-5D Visual Analog Scale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
timeFrame: Baseline, 3, 6,12 and 24 months
measure: Short Form-36 (SF-36) General Health Subscale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Short Form-36 (SF-36) Mental Health Subscale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Short Form-36 (SF-36) Social Functioning Subscale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Short Form-36 (SF-36) Physiological Functioning Subscale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Short Form-36 (SF-36) Vitality Subscale
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Resource Utilization
timeFrame: 24 months
measure: Resource Utilization Cost
timeFrame: 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Heart Center PC
state: Alabama
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Coral Springs
country: United States
facility: Holy Cross Medical Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: University Cardiology Associates, LLC
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Beltsville
country: United States
facility: Metropolitan Cardiovascular Consultants
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Medical Center
state: Massachusetts
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: San Luis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Albert Einstein University Hospital
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Saratoga Springs
country: United States
facility: Saratoga Cardiology Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Camp Hill
country: United States
facility: Capitol Area Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburg
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Dallas
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Chesapeake
country: United States
facility: Cardiovascular Associates, Ltd.
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
Study officials:
affiliation: Duke University
name: Michael Felker, MD
role: PRINCIPAL_INVESTIGATOR
References:
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