PMID- 7778529 OWN - NLM STAT- MEDLINE DCOM- 19950713 LR - 20190622 IS - 0002-9149 (Print) IS - 0002-9149 (Linking) VI - 75 IP - 18 DP - 1995 Jun 16 TI - Multicenter, randomized, placebo-controlled, double-blind study of the safety and efficacy of oral delapril in patients with congestive heart failure. PG - 18F-24F AB - A total of 101 patients (67 delapril, 34 placebo) with congestive heart failure, New York Heart Association (NYHA) classes II and III, entered a multicenter, randomized (2:1), double-blind, placebo-controlled study to determine the minimum effective and maximum tolerated doses of delapril. Patients received placebo or increasing doses of delapril. After a 2-week run-in period on placebo, patients were randomly assigned to delapril or placebo. The dose of delapril was 7.5 mg twice daily for 2 weeks, 15 mg twice daily for another 2 weeks, followed by 30 mg twice daily for 4 weeks. The dose was increased only if the patient did not present any symptoms of orthostatic hypotension. If such symptoms developed, the code was broken and an open treatment was continued on the minimum effective dose (delapril group). Patients with symptoms of orthostatic hypotension in the placebo group were withdrawn. At the end of the 8-week treatment, 36 (54.5%) patients in the delapril group completed the study on 30 mg twice daily, 12 (18.2%) on 15 mg twice daily, and 18 (27.3%) on 7.5 mg twice daily. Seven patients on placebo were withdrawn because of insufficient therapeutic response; one patient on delapril was lost to follow-up. There was a significant improvement (p < 0.01) in bicycle ergometric performance involving an increase in the exercise duration and the maximum workload tolerated in those patients completing the study on delapril 30 mg twice daily and those finishing on 15 mg twice daily.(ABSTRACT TRUNCATED AT 250 WORDS) FAU - Circo, A AU - Circo A AD - Institute of Oncology Santi Curro e Luigi Gonzaga, Catania, Italy. FAU - Platania, F AU - Platania F FAU - Mangiameli, S AU - Mangiameli S FAU - Putignano, E AU - Putignano E LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Am J Cardiol JT - The American journal of cardiology JID - 0207277 RN - 0 (Angiotensin-Converting Enzyme Inhibitors) RN - 0 (Indans) RN - W77UAL9THI (delapril) SB - IM MH - Administration, Oral MH - Aged MH - Analysis of Variance MH - Angiotensin-Converting Enzyme Inhibitors/administration & dosage/adverse effects/*therapeutic use MH - Blood Pressure/drug effects MH - Double-Blind Method MH - Exercise Test/drug effects MH - Female MH - Heart Failure/*drug therapy/physiopathology MH - Heart Rate/drug effects MH - Humans MH - Indans/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Treatment Outcome EDAT- 1995/06/16 00:00 MHDA- 1995/06/16 00:01 CRDT- 1995/06/16 00:00 PHST- 1995/06/16 00:00 [pubmed] PHST- 1995/06/16 00:01 [medline] PHST- 1995/06/16 00:00 [entrez] AID - S0002-9149(99)80510-4 [pii] AID - 10.1016/s0002-9149(99)80510-4 [doi] PST - ppublish SO - Am J Cardiol. 1995 Jun 16;75(18):18F-24F. doi: 10.1016/s0002-9149(99)80510-4.