T. Gundersen et al., ABSENCE OF EFFECT ON EXERCISE CAPACITY OF 12-WEEKS TREATMENT WITH RAMIPRIL IN PATIENTS WITH MODERATE CONGESTIVE-HEART-FAILURE, European heart journal, 15(12), 1994, pp. 1659-1665
Pharmacological therapy in cases of chronic congestive heart failure (
CHF) is usually evaluated by maximal exercise time. To assess the effe
ct of an angiotensin converting enzyme inhibitor, ramipril, 223 patien
ts with moderate CHF were studied in 24 centres in four Nordic countri
es in a randomized, double-blind, placebo-controlled, parallel group d
esign. 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 g
roup and one death in the rampiril group. A total of 195 patients comp
leted 12 weeks of treatment (placebo group n=91, ramipril group n=104)
. The groups had similar baseline characteristics. Maximal exercise ti
me was increased by mean (SD) 35 s (9) and 41 s (8) in the placebo and
rampiril groups, respectively. The adjusted difference between the gr
oups at 12 weeks was 9 s (12) (ns). A significant decrease in blood pr
essure and rate-pressure product at rest and at end of exercise was ob
tained by ramipril as compared with placebo. Significantly fewer patie
nts deteriorated in NYHA class from baseline to 12 weeks of ramipril t
reatment compared to placebo (P=0.012). Concomitant medication for CHF
increased significantly in the placebo group as compared with ramipri
l-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 fa
ilure in the placebo group. Ramipril appears to have favourable effect
s on symptoms, evaluated by NYHA classification.