A Randomized Trial of Carvedilol in Chronic Chagas Cardiomyopathy
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Chronic Chagas cardiomyopathy causes substantial morbidity and mortality in Latin America.
Whether RAS inhibitors and beta-blockers are safe and beneficial has been challenged because
of the lack of formal trials. Hence, the objective of this study was to determine the safety
and efficacy of renin-angiotensin system (RAS) inhibitors and beta-blockers in chronic Chagas
cardiomyopathy. This way, the investigators conducted a double-blind, placebo-controlled, and
randomized trial in 42 patients with Trypanosoma cruzi infection and cardiomyopathy. All
patients received enalapril (up-titrated to 20 mg BID) and spironolactone (25 mg QD).
Subsequently, the patients were randomly assigned to receive placebo (n = 20) or carvedilol
up-titrated to 25 mg BID (n = 19). The primary end points were change in left ventricular
ejection fraction (LVEF) after RAS inhibition and that after the addition of carvedilol. The
secondary end points were changes in other echocardiographic parameters, Framingham score,
quality of life (36-item Short-Form Health Survey), New York Heart Association class,
radiographic indices, brain natriuretic peptide levels, and chemokines as well as safety end
points.