OBJECTIVE: In this single-centre, prospective, randomized study, 60 patients with
dilated cardiomyopathy with an LVEF less than 40% and already receiving
digoxin,
ACE inhibitors and
diuretics for six months as the standard
therapy were randomly assigned to receive either
carvedilol (
n=30) or placebo (
n=30). Patients received an initial dosage of 3.125 mg
carvedilol or placebo twice daily for two weeks, which was then increased at two-week intervals (if tolerated), first to 6.25 mg, then to 12.5 mg, and, finally, to a target dosage of 25 mg twice daily. Clinical examinations,
radionuclide studies, and determinations of plasma levels of tumour
necrosis factor-alpha (TNF-a),
interleukin (IL)-2 and
IL-6 were performed at baseline and repeated four months after random assignment. Primary end points were New York Heart Association functional class, LV function and plasma
cytokines levels. Eight patients died (seven in the placebo group, P=0.05). Patients treated with
carvedilol had a significant improvement in functional class compared with the baseline values (P=0.001), with a decrease in the levels of
cytokines (IL-6 [P=0.001] and TNF-a [P=0.001]). LVEF increased from 22.14+/-7.85% to 27.85+/-11.80% (P=0.002), but diastolic function did not change in the
carvedilol group.
CONCLUSIONS: