Effects of amlodipine on exercise tolerance, quality of life, and left ventricular function in patients with heart failure from left ventricular systolic dysfunction

Background A preliminary study suggested that the long-acting late-generati on calcium-channel blocker amlodipine has favorable effects on exercise tol erance and is safe to use in heart failure, in contrast to earlier generati on agents. The goal of 2 multicenter studies was to assess the effect of ad junctive therapy with amlodipine in addition to standard therapy on exercis e capacity, quality of life, left ventricular function, and safety paramete rs in patients with heart failure and left ventricular systolic dysfunction . Methods Two large multicenter trials examining the effects of amlodipine on these parameters over a 12-week period of therapy were undertaken in patie nts with mild to moderate heart failure and left ventricular systolic dysfu nction. A total of 437 patients with stable heart failure were studied in a randomized, double-blind, placebo-controlled prospective design. Results Amlodipine at a dose of 10 mg/day in addition to standard therapy i n such patients was associated with no significant difference in change in exercise tolerance on a Naughton protocol compared with placebo in each tri al. Among all patients taking amlodipine, exercise time increased 53 +/- 9 (SE) seconds; exercise time for those taking placebo increased 66 +/- 9 sec onds (P = not significant). There were no significant differences in change s of quality of life parameters between amlodipine- and placebo-treated pat ients, and there were no significant differences in symptom scores or New Y ork Heart Association classification between groups. left ventricular funct ion (measured as election fraction) improved 3.4% +/- 0.5% in amlodipine-tr eated patients and 1.5% +/- 0.5% in placebo-treated patients (P = .007). Th ere was no statistically significant excess of important adverse events (ep isodes of worsening heart failure in 10% amlodipine-treated vs 6.3% of plac ebo-treated patients) or differences in need for changes in background medi cation between groups. Conclusions The addition of 10 mg of amlodipine per day to standard therapy in patients with heart failure is associated with no significant improveme nt in exercise time compared with placebo therapy over a 12-week period, an d there was no increased incidence of adverse events. These data suggest th at the addition of amlodipine to standard therapy in heart failure will not result in additional efficacy per se beyond standard therapy.