"Iso-Dinitrate Plus Hydralazine in Black Patients with Heart Failure".The New England Journal of Medicine. Year Unknown. Volume(Issue):Pages Unknown.PubMed•Full text•PDF

Contents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcomes
8.2Secondary Outcomes
9Funding
10Further Reading

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

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.

Design

- 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

Population

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

Interventions:

- 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

Outcomes

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

Secondary Outcomes:
- 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

Funding

The study was funded by NitroMed.

Further Reading

The additional details, appendix, and specific author affiliations are available with the full text of the article.