"Iso-Dinitrate Plus Hydralazine in Black Patients with Heart Failure".The New England Journal of Medicine. Year Unknown. Volume(Issue):Pages Unknown.
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Does the addition of a fixed dose combination of isosorbide dinitrate and hydralazine to standard therapy for heart failure improve outcomes in black patients with advanced heart failure?
The addition of isosorbide dinitrate plus hydralazine to standard therapy, including neurohormonal blockers, significantly increased survival and improved quality of life among black patients with advanced heart failure.
The African-American Heart Failure Trial (A-HeFT) demonstrated that a combination of isosorbide dinitrate and hydralazine added to standard heart failure therapy, including neurohormonal inhibitors, was effective in reducing mortality and improving quality of life in black patients with moderate-to-severe heart failure.
As a result of the study findings, guidelines may now endorse the combination of isosorbide dinitrate plus hydralazine as part of standard therapy for black patients with advanced heart failure.
- Randomized, placebo-controlled, double-blind trial - Patients recruited from 161 centers in the United States - Enrollment: 1050 black patients with NYHA class III or IV heart failure with dilated ventricles - Interventions: Fixed dose of isosorbide dinitrate plus hydralazine vs. placebo, in addition to standard therapy - Follow-up: Up to 18 months
Inclusion Criteria: - Black patients aged 18 and older - NYHA class III or IV heart failure for at least three months - Left ventricular ejection fraction ≤35% or <45% with increased left ventricular internal end-diastolic diameter - Stable doses of standard therapy for heart failure, including neurohormonal blockers
Exclusion Criteria: - Acute myocardial infarction, acute coronary syndrome, or stroke within the preceding three months - Cardiac surgery or intervention within the preceding three months - Significant valvular disease, hypertrophic or restrictive cardiomyopathy, uncontrolled hypertension, and other specific cardiac conditions - Pregnancy, nursing, not using effective contraception if of childbearing age - Life expectancy-limiting illness other than heart failure
Baseline Characteristics: - Mean age, gender distribution, and baseline comorbid conditions were balanced between the two groups
- Fixed-dose combination of isosorbide dinitrate and hydralazine or placebo - Initially one tablet containing either 37.5 mg of hydralazine hydrochloride and 20 mg of isosorbide dinitrate or placebo three times daily - Increased to two tablets three times daily
Primary Outcomes: - Primary endpoint was a composite score consisting of death from any cause, a first hospitalization for heart failure, and change in quality of life
- Individual components of the primary composite score - Cardiovascular death - Total number and days of hospitalization - Quality of life over the trial - Unscheduled healthcare visits - Change in B-type natriuretic peptide level - Need for cardiac transplantation - Change in left ventricular ejection fraction, internal diastolic dimension, and wall thickness
The study was funded by NitroMed.
The additional details, appendix, and specific author affiliations are available with the full text of the article.