Comparison of the Effects of Cilazapril and Captopril versus Placebo on Exercise Testing in Chronic Heart Failure Patients: A Double-Blind, Randomized, Multicenter Tria

Abstract

In order to compare directly the efficacy of two different angiotensin-converting enzyme (ACE) inhibitors in terms of clinical status and exercise capacity, 443 patients with chronic heart failure (New York Heart Association classes II-IV) were randomized into a 24-week double-blind study to receive cilazapril (CLZ) 1-2.5 mg once daily (n = 221), captopril (CPT) 25-50 mg three times daily (n = 108), or placebo (PLA) for 12 weeks followed by CLZ 2.5 mg (n = 114) in addition to their standard heart failure therapy. The majority were New York Heart Association functional class II (56-62%), and the most frequent etiology of chronic heart failure was coronary heart disease (35-42%), followed by dilative cardiomyopathy (approximately 28%). Both ACE inhibitors prolonged the exercise tolerance test duration at all visits, and the effect at week 12 (CLZ 62.2 +/- 7.5 s; CPT 73.1 +/- 10.7 s) was significantly greater than after PLA (28.1 +/- 12.2 s; p = 0.011 and p = 0.005, respectively). Furthermore, the distance walked during 6 min increased at all visits with ACE inhibitors (NS vs. PLA). CLZ was more effective in patients with the most impaired physical ability at baseline as defined by exercise tolerance test duration < or = 6 min (p = 0.0036 at week 12 and p = 0.0150 at week 24) and by walking test < or = 400 m (p = 0.0004 at week 12 and p = 0.0009 at week 24). Similar results were obtained with CPT for the walking test (p = 0.0369 at week 12 and p = 0.0142 at week 24).(ABSTRACT TRUNCATED AT 250 WORDS)