EFFECT OF THE CALCIUM-ANTAGONIST FELODIPINE AS SUPPLEMENTARY VASODILATOR THERAPY IN PATIENTS WITH CHRONIC-HEART-FAILURE TREATED WITH ENALAPRIL - V-HEFT-III

Background Despite therapy with diuretics, ACE inhibitors and digoxin morbidity and mortality in heart failure remain high and might respond favorably to an additional vasodilator. Methods and Results Male pati ents (n=450) with chronic heart failure (cardiac dysfunction and impai red exercise performance) on optimal current therapy (97% enalapril, 8 9% diuretics) were randomly assigned to double-blind treatment with fe lodipine extended release (5 mg BID) or placebo for 3 to 39 months (av erage, 18 months). Felodipine significantly reduced blood pressure and , at 3 months, increased ejection fraction (2.1% versus -0.1% units in the placebo group, P=.001) and reduced plasma atrial natriuretic pept ide levels (-2.9 versus 26.9 pg/mL in the placebo group, P=.01) but di d not improve exercise tolerance, quality of life, or the need for hos pitalization. During long-term follow-up, the favorable effects on eje ction fraction and atrial peptide did not persist, but felodipine prev ented worsening exercise tolerance and quality of life. In the felodip ine and placebo groups, mortality (13.8% versus 12.8%, respectively) a nd hospitalization (43% versus 42%) rates were similar, and a higher i ncidence of peripheral edema was the only apparent side effect of felo dipine therapy. Conclusions Felodipine exerts a well-tolerated additio nal sustained vasodilator effect in patients with heart failure treate d with enalapril, but the only possible long-term benefit was a trend for better exercise tolerance and less depression of quality of life i h the second year of treatment. The drug appears to be safe but not cl early efficacious in patients with heart failure.