Sl. Olsen et al., CARVEDILOL IMPROVES LEFT-VENTRICULAR FUNCTION AND SYMPTOMS IN CHRONICHEART-FAILURE - A DOUBLE-BLIND RANDOMIZED STUDY, Journal of the American College of Cardiology, 25(6), 1995, pp. 1225-1231
Objectives. This study assessed the safety and efficacy of carvedilol
in patients with heart failure caused by idiopathic or ischemic cardio
myopathy. Background. Carvedilol is a mildly beta(1)-selective beta-ad
renergic blocking agent with vasodilator properties. Beta-blockade may
be beneficial in patients with heart failure, but the effects of carv
edilol are not known. Methods. Sixty patients with heart failure (New
York Heart Association functional classes II to IV) and left ventricul
ar ejection fraction less than or equal to 0.35 were enrolled in the s
tudy. All patients tolerated challenge with carvedilol, 3.125 mg twice
a day, and were randomized to receive carvedilol (n = 36) versus plac
ebo (n = 24). Study medication was titrated over 1 month from 6.25 to
25 mg twice a day (<75 kg) or 50 mg twice a day (>75 kg) and continued
for 3 months. One placebo treated and two carvedilol-treated patients
did not complete the study. Results. Carvedilol therapy resulted in a
significant reduction in heart rate and mean pulmonary artery and pul
monary capillary wedge pressures and a significant increase in stroke
volume and left ventricular stroke work. Left ventricular ejection fra
ction increased 52% in the carvedilol group (from 0.21 to 0.32, p < 0.
0001 vs. placebo group). Carvedilol-treated patients also reported a s
ignificant lessening of heart failure symptoms (p < 0.05 vs. placebo g
roup). Submaximal exercise duration tended to increase with carvedilol
therapy (from 688 +/- 31 s to 871 +/- 32 s), but this change was not
significantly different from that with placebo therapy by between-grou
p analysis. Peak oxygen consumption during maximal exercise did not ch
ange. Conclusions. Long-term carvedilol therapy improves rest cardiac
function and lessens symptoms in patients with heart failure.