This 12-month, multicenter, randomized, parallel-group study compared the e
ffects of delapril with enalapril in 179 patients with congestive heart fai
lure, New York Heart Association (NYHA) classes II and III. The initial dos
es of delapril (7.5 mg twice daily [BID]) and enalapril (2.5 mg BID) could
be doubled every other week, to a maximum of 30 mg BID and 10 mg BID, respe
ctively. Efficacy was assessed based on the changes in NYHA class, echocard
iographic variables, cardiothoracic ratio, left ventricular end-diastolic v
olume, left ventricular end-systolic volume, left ventricular systolic wall
stress, ejection fraction results of the exercise test, and patient's opin
ion of clinical status using a 4-point scale. Safety was assessed by monito
ring the adverse events, laboratory tests, blood pressure, and electrocardi
ography. A significant decrease in left ventricular end-systolic volume was
observed in the delapril group after 3 (P < 0.01), 6 (P < 0.01), and 12 (P
< 0.05) months; no significant changes were seen in the enalapril group in
this period. Both treatments significantly reduced wall stress and improve
d ejection fraction at 3 (delapril, P < 0.01; enalapril, P < 0.05), 6 (P <
0.01 for both groups), and 12 (delapril, P < 0.01; enalapril, P < 0.05) mon
ths, and significantly improved ejection fraction (P < 0.01). None of the b
etween-group differences were significant. Both treatments produced a signi
ficant improvement compared with baseline in the duration of exercise, work
load, and work performed at 3 and 12 months. There was a significant differ
ence between treatments in workload at 3 months (P < 0.05) in favor of dela
pril. Heart rate was significantly reduced at day 30 (P < 0.01), day 45 (P
< 0.05), and month 6 (P < 0.05) only in the delapril group. The frequency a
nd type of adverse events were similar in the 2 groups. One-year mortality
was 5.7% in the delapril group and 6.6% in the enalapril group. These resul
ts suggest that treatment with delapril, an angiotens-inconverting enzyme (
ACE) inhibitor with affinity and selectivity for the C-site of the left ven
tricle and coronary arteries, may have some modest benefits when compared w
ith a nonselective ACE: inhibitor such as enalapril. However, more study is
needed in larger patient populations.