The BENEFIT trial: testing the hypothesis that trypanocidal therapy is beneficial for patients with chronic Chagas heart disease.
Among the pathophysiological derangements operating in the chronic phase of Chagas disease, parasite persistence is likely to constitute the main mechanism of myocardial injury in patients with chronic chagasic cardiomyopathy. The presence of Trypanosoma cruzi in the heart causes a low-grade, but relentless, inflammatory process and induces myocardial autoimmune injury. These facts suggest that trypanocidal therapy may positively impact the clinical course of patients with chronic Chagas heart disease. However, the experimental and clinical evidence currently available is insufficient to support the routine use of etiologic treatment in these patients. The BENEFIT project--Benznidazole Evaluation for Interrupting Trypanosomiasis--is an international, multicenter, double-blind, placebo-controlled trial of trypanocidal treatment with benznidazole in patients with chronic Chagas heart disease. This project is actually comprised of two studies. The pilot study investigates whether etiologic treatment significantly reduces parasite burden, as assessed by polymerase chain reaction-based techniques and also determines the safety and tolerability profile of the trypanocidal drug in this type of chagasic population. The full-scale study determines whether antitrypanosomal therapy with benznidazole reduces mortality and other major cardiovascular clinical outcomes in patients with chronic Chagas heart disease.
Marin-Neto
J Antonio
JA
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil. marin_neto@yahoo.com
Rassi
Anis
A
Avezum
Alvaro
A
Mattos
Antonio C
AC
Rassi
Anis
A
Morillo
Carlos A
CA
Sosa-Estani
Sergio
S
Yusuf
Salim
S
D000818:Animals; D002598:Chagas Cardiomyopathy / Q000188:drug therapy* / Q000469:parasitology; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D019317:Evidence-Based Medicine; D006801:Humans; D009593:Nitroimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D018579:Patient Selection; D010865:Pilot Projects; D014344:Trypanocidal Agents / Q000008:administration & dosage* / Q000627:therapeutic use
D009593:Nitroimidazoles; D014344:Trypanocidal Agents; C009999:benzonidazole