| Rationale and design of a randomized placebo-controlled trial assessing the effects of etiologic treatment in Chagas' cardiomyopathy: the BENznidazole Evaluation For Interrupting Trypanosomiasis (BENEFIT). | |
| | |
MedLine Citation:
|
PMID: 18585495 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: Benznidazole is effective for treating acute and chronic (recently acquired) Trypanosoma cruzi infection (Chagas' disease). Recent data indicate that parasite persistence plays a pivotal role in the pathogenesis of chronic Chagas' cardiomyopathy. However, the efficacy of trypanocidal therapy in preventing clinical complications in patients with preexisting cardiac disease is unknown. STUDY DESIGN: BENEFIT is a multicenter, randomized, double-blind, placebo-controlled clinical trial of 3,000 patients with Chagas' cardiomyopathy in Latin America. Patients are randomized to receive benznidazole (5 mg/kg per day) or matched placebo, for 60 days. The primary outcome is the composite of death; resuscitated cardiac arrest; sustained ventricular tachycardia; insertion of pacemaker or cardiac defibrillator; cardiac transplantation; and development of new heart failure, stroke, or systemic or pulmonary thromboembolic events. The average follow-up time will be 5 years, and the trial has a 90% power to detect a 25% relative risk reduction. The BENEFIT program also comprises a substudy evaluating the effects of benznidazole on parasite clearance and an echo substudy exploring the impact of etiologic treatment on left ventricular function. Recruitment started in November 2004, and >1,000 patients have been enrolled in 35 centers from Argentina, Brazil, and Colombia to date. CONCLUSION: This is the largest trial yet conducted in Chagas' disease. BENEFIT will clarify the role of trypanocidal therapy in preventing cardiac disease progression and death. |
| | |
Authors:
|
Jose Antonio Marin-Neto; Anis Rassi; Carlos A Morillo; Alvaro Avezum; Stuart J Connolly; Sergio Sosa-Estani; Fernando Rosas; Salim Yusuf; |
Related Documents
:
|
15851165 - Trends in treated ventricular fibrillation out-of-hospital cardiac arrest: a 17-year po... 9101355 - Effects of mndpdp, dpdp--, and mncl2 on cardiac energy metabolism and manganese accumul... 17951365 - Mechanisms of calcium transient and action potential alternans in cardiac cells and tis... 10699695 - Incidence, duration and survival of ventricular fibrillation in out-of-hospital cardiac... 15111135 - Does preoperative atrial fibrillation reduce survival after coronary artery bypass graf... 15646575 - Percutaneous transcatheter coil embolization of a ventricular septal defect in a dog. |
Publication Detail:
|
Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: American heart journal Volume: 156 ISSN: 1097-6744 ISO Abbreviation: Am. Heart J. Publication Date: 2008 Jul |
Date Detail:
|
Created Date: 2008-06-30 Completed Date: 2008-07-31 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 0370465 Medline TA: Am Heart J Country: United States |
Other Details:
|
Languages: eng Pagination: 37-43 Citation Subset: AIM; IM |
Affiliation:
|
Medical School of Ribeirao Preto, University of Sao Paulo, Ribeirão Preto, Sao Paulo, Brazil. marin_neto@yahoo.com |
| Data Bank Information | |
Bank Name/Acc. No.:
|
ClinicalTrials.gov/NCT00123916; ISRCTN/ISRCTN13967269 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Chagas Cardiomyopathy
/
diagnosis,
drug therapy*,
etiology*,
mortality Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Evaluation Studies as Topic Female Follow-Up Studies Humans Latin America Male Nitroimidazoles / therapeutic use* Pilot Projects Risk Assessment Severity of Illness Index Survival Analysis Time Factors Treatment Outcome Trypanosomiasis / complications*, diagnosis, drug therapy* |
| Chemical | |
Reg. No./Substance:
|
0/Nitroimidazoles; 22994-85-0/benzonidazole |
| Investigator | |
Investigator/Affiliation:
|
S Yusuf / ; J A Marin-Neto / ; C A Morillo / ; A Rassi / ; A Rassi / ; A Avezum / ; S J Connolly / ; S Sosa-Estani / ; F Rosas / ; C Britto / ; J Lazdins / ; B Ramos / ; C Morillo / ; A Avezum / ; S Yusuf / ; J A Marin-Neto / ; R Oliveira / ; L Dyal / ; H Penna-Guimarães / ; A C Mattos / ; A Rassi / ; C Britto / ; S Sosa-Estani / ; E Segura / ; F Rosas / ; F Guhl / ; J Lazdins / ; B C Maciel / ; P Sleight / ; H Acquatella / ; J Lazzari / ; D Sackett / ; R Robins / ; C Morillo / ; S Yusuf / ; B Ramos / ; R Oliveira / ; A Avezum / ; H Penna-Guimaraes / ; A C Mattos / ; J R Zappiello-Mendes / ; Juarez Braga / ; J A Marin-Neto / ; B C BC Maciel / ; Tonani / ; S Sosa-Estani / ; T A Orduna / ; F A Silva-Nieto / ; M P Bernachea / ; R Carrizo Pae / ; R Manzur / ; C A Cuneo / ; G Perez-Pardos / ; J Beloscar / ; E Oshiro / ; M C Bangher / ; L Gomes / ; V I Volberg / ; M Mallagray / ; A Rassi Jr / ; A Luquetti / ; A Schmidt / ; A A Fragata Filho / ; L Nigro-Maia / ; A M L Lorga / ; A S Souza / ; R C Pedrosa / ; E D Gontijo / ; W A Oliveira Jr / ; R Aras / ; G S Feitosa / ; A Prata / ; T L Silva / ; A A Steffens / ; C L P Cunha / ; L F A Oliveira / ; A C Carvalho / ; A C A Souza / ; J F K Saraiva / ; C Mady / ; E A Bocchi / ; G Reis / ; A A Fagundes / ; F Rosas / ; S Navarrete / ; R Quiroz / ; R Onate / ; E Villena / ; B Arana / ; A Laguna / ; R Espinosa / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug covera...
Next Document: The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-...