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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)

The American heart journal, 2008-07, Vol.156 (1), p.37-43 [Peer Reviewed Journal]

Mosby, Inc. ;2008 Mosby, Inc. ;2008 INIST-CNRS ;Copyright Elsevier Limited Jul 2008 ;ISSN: 0002-8703 ;EISSN: 1097-6744 ;DOI: 10.1016/j.ahj.2008.04.001 ;PMID: 18585495 ;CODEN: AHJOA2

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Title:
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)
Author: Marin-Neto, Jose Antonio, MD ; Rassi, Anis, MD ; Morillo, Carlos A., MD ; Avezum, Alvaro, MD ; Connolly, Stuart J., MD ; Sosa-Estani, Sergio, MD ; Rosas, Fernando, MD ; Yusuf, Salim, MD
Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiparasitic agents ; Biological and medical sciences ; Cardiac arrhythmia ; Cardiology. Vascular system ; Cardiomyopathy ; Cardiovascular ; Cardiovascular disease ; Chagas Cardiomyopathy - diagnosis ; Chagas Cardiomyopathy - drug therapy ; Chagas Cardiomyopathy - etiology ; Chagas Cardiomyopathy - mortality ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Evaluation Studies as Topic ; Female ; Follow-Up Studies ; Heart ; Heart failure ; Human protozoal diseases ; Humans ; Hypotheses ; Infections ; Infectious diseases ; Latin America ; Male ; Medical sciences ; Mortality ; Myocarditis. Cardiomyopathies ; Nitroimidazoles - therapeutic use ; Parasites ; Parasitic diseases ; Pathogenesis ; Pharmacology. Drug treatments ; Pilot Projects ; Polymerase chain reaction ; Protozoal diseases ; Risk Assessment ; Rodents ; Severity of Illness Index ; Sinuses ; Studies ; Survival Analysis ; Time Factors ; Treatment Outcome ; Tropical diseases ; Trypanosomiasis ; Trypanosomiasis - complications ; Trypanosomiasis - diagnosis ; Trypanosomiasis - drug therapy
Is Part Of: The American heart journal, 2008-07, Vol.156 (1), p.37-43
Description: 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.
Publisher: New York, NY: Mosby, Inc
Language: English
Identifier: ISSN: 0002-8703
EISSN: 1097-6744
DOI: 10.1016/j.ahj.2008.04.001
PMID: 18585495
CODEN: AHJOA2
Source: AUTh Library subscriptions: ProQuest Central
MEDLINE

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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)

Mosby, Inc. ;2008 Mosby, Inc. ;2008 INIST-CNRS ;Copyright Elsevier Limited Jul 2008 ;ISSN: 0002-8703 ;EISSN: 1097-6744 ;DOI: 10.1016/j.ahj.2008.04.001 ;PMID: 18585495 ;CODEN: AHJOA2

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