Prospective Randomized Amlopidine Survival Evaluation - PRAISE

Description:

Amlodipine vs placebo for mortality and cardiovascular morbidity in severe chronic heart failure.

Hypothesis:

Is the use of the calcium-channel antagonist amlopidine in patients with severe chronic heart failure safe and/or efficacious?

Study Design

Study Design:

Patients Screened: not reported
Patients Enrolled: 1153
NYHA Class: IIIB or IV
Mean Follow Up: 6-33 months (median 13.8)
Mean Patient Age: average 65 years
Female: 24%
Mean Ejection Fraction: <30%

Patient Populations:

NYHA Class IIIB or IV and ejection fraction <30% despite therapy with digoxin, diuretics, and an ACE inhibitor

Exclusions:

Unstable angina or MI in prior month, cardiac arrest or sustained ventricular tachycardia or ventricular fibrillation in prior year, stroke or cardiac revascularization in prior 3 months, SBP <85 mm Hg or ≥160 mm Hg, active myocarditis, constrictive pericarditis, uncorrected primary valvular disease, severe concomitant disease, serum creatinine >3.0 mg/dL

Primary Endpoints:

Mortality and cardiovascular morbidity (hospitalization for 24 hours for MI, pulmonary edema, severe hypoperfusion, ventricular tachycardia or ventricular fibrillation)

Secondary Endpoints:

all cause mortality

Drug/Procedures Used:

Amlopidine 10 mg/day (5 mg/day x 2 weeks) or placebo. Nitrates allowed but other vasodilators, beta-blockers, calcium channel blockers, and Class IC antiarrhyhtmic agents were prohibited

Principal Findings:

The amlopidine group had a nonsignificant 9% lower incidence of the primary endpoint (39% vs. 42%; p = 0.31). Amlodipine group also had a nonsignificant 16% mortality reduction (33% vs. 38%; p = 0.07). Among nonischemic patients (63.5% of enrolled patients), amlopidine was associated with a 46% lower mortality rate (p < 0.001) and 31% lower incidence of primary endpoint(p = 0.04).

Interpretation:

Amlodipine was not associated with a significant increase or decrease in mortality and morbidity among patients with severe CHF.

References:

N Engl J Med 1996;335: 1107–1114.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Morbidity, Digoxin, Nitrates, Diuretics, Heart Failure, Amlodipine, Calcium Channel Blockers, Vasodilator Agents


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