Back to Search
Start Over
African-American Heart Failure Trial (A-HeFT): rationale, design, and methodology
African-American Heart Failure Trial (A-HeFT): rationale, design, and methodology
- Source :
- Journal of cardiac failure. 8(3)
- Publication Year :
- 2002
-
Abstract
- Hydralazine and isosorbide dinitrate combination (H+ISDN), angiotensin-converting enzyme inhibitors, and beta-blockers have improved outcomes in heart failure (HF). Analysis of previous trials has shown that H+ISDN appears especially beneficial in African American patients.The African-American Heart Failure Trial (A-HeFT) is double-blind, placebo-controlled, and includes African American patients with stable New York Heart Association Class III-IV HF on standard therapy. Patients must have prior HF-related events and left ventricular ejection fraction (LVEF)or = 35% or LVEF45% with left ventricular internal diastolic dimension2.9 cm/m(2). Randomization to addition of placebo or BiDil (Nitro Med, Inc., Bedford, MA), a fixed combination of H+ISDN, is stratified for beta-blocker usage. All patients are treated and followed until the last patient entered completes 6 months of follow-up. The primary efficacy endpoint is a composite score including quality of life, death, and hospitalization for HF. At least 600 patients will be randomized; the first was randomized in June 2001.In addition to providing additional information on BiDil efficacy in HF, A-HeFT is the first HF trial aimed at a selected subgroup of patients and the first to use a new composite HF score as its primary efficacy endpoint.
- Subjects :
- Adult
Male
medicine.medical_specialty
New York Heart Association Class
Randomization
Adolescent
Vasodilator Agents
Black People
Isosorbide Dinitrate
Placebo
law.invention
Ventricular Dysfunction, Left
Randomized controlled trial
Double-Blind Method
law
Internal medicine
medicine
Humans
Aged
Heart Failure
Ejection fraction
Informed Consent
business.industry
Patient Selection
Middle Aged
medicine.disease
Hydralazine
Clinical trial
Drug Combinations
Treatment Outcome
Research Design
Heart failure
Cardiology
Female
Isosorbide dinitrate
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 10719164
- Volume :
- 8
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Journal of cardiac failure
- Accession number :
- edsair.doi.dedup.....4f20df7a42b48b22dedba7f1bf42dbdb