The purpose of this study is to determine if 60 days with treatment with an antiparasital drug (benznidazole) could prevent the development of cardiac disease in patients with Chagas Disease.

Condition	Intervention	Phase
Chagas Disease Trypanosomiasis Chronic Heart disease	Drug: Benznidazole	Phase III

Further Study Details: 

Primary Outcomes: the first occurrence of any of the following clinically significant outcomes:; 1. Death; 2. Cardiac arrest, requiring defibrillator or cardioversion; 3. Documented sustained ventricular tachycardia requiring cardioversion; 4. New development of symptomatic congestive heart failure; 5. Pacemaker or implantable cardiac defibrillator implantation; 6. Stroke or any other thromboembolic event in patients with no prior thromboembolic phenomena
Secondary Outcomes: 1. New development of any of the following echo changes clinically indicated or done for the trial: segmental wall motion abnormalities, ventricular aneurysm, reduction in LV ejection fraction > 5%; increase in LVDD > 5.0 mm compared with baseline; 2. New 12 lead ECG alterations (complete bundle branch block; fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc; 3. Progression of NYHA functional class by at least one category.; 4. Evaluation of safety (adverse events: dermatitis, peripheral neuropathy, gastro-intestinal intolerance; leucopenia (2500 x 10 9 L), tolerance and adherence to treatment
Expected Total Enrollment:  3000

A randomized double-blind controlled clinical trial of Benznidazole in patients with chronic Chaga''''s heart disease. Chagas disease has 3 phases: acute, indetermined and chronic phases.There are no clinical trials up to date that have investigated the use of antiparasitic drugs in patients that are in the chronic phase. This study will evaluate the efficacy and safety of benznidazole (an antiparasitic drug) in patients with Chronic Chagas heart disease. It will evaluate if 60 days of drug treatment will reduce mortality and morbidity in patients with Chronic Chagas heart disease.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria: Consenting patients (between 18 and 65 years of age)with serological evidence of Chagas infection (any combination of 2 positive tests) and that have one or more of the following:

• Abnormal Electrocardiogram with at least two components (complete RBBB or LBBB; left anterior or posterior fascicular block; ventricular premature beat; first degree AV block; mobitz type I AV block; sinus bradycardia; primary ST-T changes; abnormal Q waves; low voltage QRS; or atrial fibrillation)
• Abnormal ECG (Mobitz type II, advanced or third degree AV block)
• Increased cardiothoracic ratio (> 0.50)
• Complex ventricular arrythmias on 24hr ambulatory ECG monitoring
• Evidence of regional wall motion abnormality or reduced global left ventricular systolic function or increased left ventricular and diastolic diameter on 2D-Echo.

Exclusion Criteria: Patients will be excluded if having:

• NYHA heart failure class IV or decompensated heart failure
• Evidence of concomitant CAD or other etiology of dilated cardiomyopathy
• Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy
• Inability to comply with follow-up visits
• History of severe alcohol abuse within 2 years
• Known chronic renal or hepatic insufficiency
• Pregnancy or breast feeding
• Megaesophagus with swallowing impairment
• Other severe disease significantly curtailing life expectancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00123916

Carlos Morillo, MD, PhD      1-905-527-4322  Ext. 44386    benefit@phri.ca
Alvaro Avezum, MD,PhD      55-11-5085-4204    benefit@phri.ca

Argentina
      CenDIE, Buenos Aires,  Argentina; Not yet recruiting
Brazil
      Dante Pazzanese Instituto de Cardiologia, Sao Paulo,  04012-180,  Brazil; Recruiting
Brazil, Sao paulo
      FAEPA-Faculdade de Medicina de Ribeirao Preto, Ribeirao Preto,  Sao paulo,  14090-100,  Brazil; Recruiting
Canada, Ontario
      Population Health Research Institute - McMaster University, Hamilton,  Ontario,  L8L 2X2,  Canada; Recruiting

Study chairs or principal investigators

Carlos Morillo,  Principal Investigator,  McMaster University   

Study ID Numbers:  BEN01; CONEP-11394
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 25, 2005
ClinicalTrials.gov Identifier:  NCT00123916
Health Authority: Brazil: Committee of Ethics in Research
ClinicalTrials.gov processed this record on 2005-07-26