Copyright © 1994 by the European Society of Cardiology.
© 1994 The European Society of Cardiology
Absence of effect on exercise capacity of 12-weeks treatment with ramipril in patients with moderate congestive heart failure
ON BEHALF OF THE RAMIPRIL STUDY GROUP¶,
*Cardiology Division, Medical Department, Aust-Agder Central Hospital Arendal, Norway
Cardiology Division, Medical Department, Östra Hospital Göteborg, Sweden
Department of Cardiology, Gentofte Hospital Hellerup, Denmark
Department of Medicine, Kuopio University Hospital Kuopio, Finland
||Cardiovascular Medicine, Astra Hässle AB Mölndal, Sweden
Received 3 February 1993; revised 22 April 1994; .
The participants in the Ramipril Trial Study Group are listed in the Appendix. Correspondence. Torstein Gundersen, Medical Department, Aust-Agder Central Hospital, 4800 Arendal, Norway.
Abstract
Pharmacological therapy in cases of chronic congestive heart failure (CHF) is usually evaluated by maximal exercise time. To assess the effect of an angiotensin converting enzyme inhibitor, ramipril, 223 patients with moderate CHF were studied in 24 centres in four Nordic countries in a randomized, double-blind, placebo-controlled, parallel group design.
The study drug was titrated from 1.25 mg to a maximum of 10 mg once daily (o.d) over a period of 4 weeks (mean dose 8 mg). A symptom-limited bicycle exercise test, starting at 30 watts and increasing by 10 watts. min –1, was used to evaluate exercise capacity. Reproducible tests were required at baseline, and the test was repeated after 4, 8 and 12 weeks of treatment.
Seven deaths were recorded in the placebo group and one death in the ramipril group. A total of 195 patients completed 12 weeks of treatment (placebo group n=91, ramipril group n = 104). The groups had similar baseline characteristics. Maximal exercise time was increased by mean (SD) 35 s (9) and 41 s (8) in the placebo and ramipril groups, respectively. The adjusted difference between the groups at 12 weeks was 9 s (12) (ns). A significant decrease in blood pressure and rate-pressure product at rest and at end of exercise was obtained by ramipril as compared with placebo. Significantly fewer patients deteriorated in NYHA class from baseline to 12 weeks of ramipril treatment compared to placebo (P=0.012). Concomitant medication for CHF increased significantly in the placebo group as compared with ramipril-treated patients (P=0.003).
In conclusion, maximal exercise time was not significantly improved by ramipril, compared with placebo, which might be the result of an increase in concomitant therapy for heart failure in the placebo group. Ramipril appears to have favourable effects on symptoms, evaluated by NYHA classification.
Key Words: Exercise capacity • ACE inhibition • bicycle test • heart failure
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