PMID- 11127445 OWN - NLM STAT- MEDLINE DCOM- 20010111 LR - 20190708 IS - 0735-1097 (Print) IS - 0735-1097 (Linking) VI - 36 IP - 7 DP - 2000 Dec TI - Outcome of patients with congestive heart failure treated with standard versus high doses of enalapril: a multicenter study. High Enalapril Dose Study Group. PG - 2090-5 AB - OBJECTIVES: We sought to prospectively and randomly compare survival with clinical and hemodynamic variables in patients with congestive heart failure (CHF) treated with standard versus high doses of enalapril. BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors produce hemodynamic and symptomatic benefits in patients with CHF, but there is still controversy about the optimal dose in this clinical setting. METHODS: Two hundred and forty-eight patients with advanced CHF (age 56.3+/-12 years) were randomized to receive a maximal tolerated dose of enalapril, up to 20 mg/day in group 1 (mean dose achieved 17.9+/-4.3 mg/day, n = 122) and 60 mg/day in group 2 (mean dose achieved 42+/-19.3 mg/day, n = 126). RESULTS: At enrollment, patients in group 1 were in New York Heart Association (NYHA) functional class 2.6+/-0.7 and had a mean systolic blood pressure (SBP) of 117+/-18 mm Hg, a mean heart rate (HR) of 85+/-16 beats/min and a left ventricular ejection fraction (LVEF) of 20.0+/-9.8%. In group 2, patients were in NYHA class 2.6+/-0.7; their SBP was 118+/-17 mm Hg, HR 83+/-15 beats/min and LVEF 18.8+/-8.1%. There were no significant differences in these characteristics between the two groups of patients at enrollment. After 12 months of follow-up, 22 (18%) of 122 patients in group 1 and 23 (18%) of 126 patients in group 2 had died (p = 0.995, with 80% power of the study to detect a delta difference of 13%). The NYHA class was the same (1.9+/-0.7) in both groups; SBP was 111+/-16 and 111+/-17 mm Hg, HR 77+/-12 and 79+/-13 beats/min and LVEF 31+/-19% and 30+/-12% in groups 1 and 2, respectively. These differences were not statistically significant. The study had a power of 80% to detect (p = 0.05) the following changes: 13% in death rate, 0.25 units in NYHA class, 6 mm Hg in SBP, 5 beats/min in HR and 6% in LVEF. CONCLUSIONS: No significant differences were found in survival and clinical and hemodynamic variables between patients receiving standard and those receiving high doses of enalapril. FAU - Nanas, J N AU - Nanas JN AD - University of Athens School of Medicine, Department of Clinical Therapeutics, Alexandra Hospital, Greece. FAU - Alexopoulos, G AU - Alexopoulos G FAU - Anastasiou-Nana, M I AU - Anastasiou-Nana MI FAU - Karidis, K AU - Karidis K FAU - Tirologos, A AU - Tirologos A FAU - Zobolos, S AU - Zobolos S FAU - Pirgakis, V AU - Pirgakis V FAU - Anthopoulos, L AU - Anthopoulos L FAU - Sideris, D AU - Sideris D FAU - Stamatelopoulos, S F AU - Stamatelopoulos SF FAU - Moulopoulos, S D AU - Moulopoulos SD LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Angiotensin-Converting Enzyme Inhibitors) RN - 69PN84IO1A (Enalapril) SB - IM CIN - J Am Coll Cardiol. 2000 Dec;36(7):2096-7. PMID: 11127446 MH - Adolescent MH - Adult MH - Aged MH - Angiotensin-Converting Enzyme Inhibitors/*administration & dosage MH - Enalapril/*administration & dosage MH - Female MH - Heart Failure/*drug therapy/mortality/physiopathology MH - Hemodynamics/drug effects MH - Humans MH - Male MH - Middle Aged MH - Prognosis MH - Survival Analysis MH - Treatment Outcome EDAT- 2000/12/29 11:00 MHDA- 2001/02/28 10:01 CRDT- 2000/12/29 11:00 PHST- 2000/12/29 11:00 [pubmed] PHST- 2001/02/28 10:01 [medline] PHST- 2000/12/29 11:00 [entrez] AID - S0735109700010251 [pii] AID - 10.1016/s0735-1097(00)01025-1 [doi] PST - ppublish SO - J Am Coll Cardiol. 2000 Dec;36(7):2090-5. doi: 10.1016/s0735-1097(00)01025-1.