Cardiomyopathy Clinical Trial
Official title:
A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
The benefits of exercise training in heart failure are well established. Its effects, however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis is that the exercise training may improve functional capacity, quality of life (QoL), and reduce brain natriuretic peptide (BNP) levels in patients with ChC.
Status | Completed |
Enrollment | 37 |
Est. completion date | March 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Chronic Chagas dilated cardiomyopathy, defined by the echocardiography finding of a dilated left ventricle with moderate or severe impaired left ventricular systolic function (left ventricular ejection fraction = 45%). - To be clinically stable for at least 3 months - To have sinus rhythm - To be under standard medical therapy use at the time. Exclusion Criteria: - Inability to attend regular exercise training - The presence of a pacemaker, associated cardiac or systemic diseases - Practitioners of regular physical activity |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Minas Gerais | Belo Horizonte | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais |
Brazil,
Lima MM, Nunes MC, Nascimento B, Costa HS, Sousa LA, Teixeira AL, Rocha MO, Ribeiro AL. Improvement of the functional capacity is associated with BDNF and autonomic modulation in Chagas disease. Int J Cardiol. 2013 Sep 1;167(5):2363-6. doi: 10.1016/j.ijca — View Citation
Lima MM, Nunes MC, Rocha MO, Beloti FR, Alencar MC, Ribeiro AL. Left ventricular diastolic function and exercise capacity in patients with Chagas cardiomyopathy. Echocardiography. 2010 May;27(5):519-24. doi: 10.1111/j.1540-8175.2009.01081.x. Epub 2010 Apr — View Citation
Lima MM, Rocha MO, Nunes MC, Sousa L, Costa HS, Alencar MC, Britto RR, Ribeiro AL. A randomized trial of the effects of exercise training in Chagas cardiomyopathy. Eur J Heart Fail. 2010 Aug;12(8):866-73. doi: 10.1093/eurjhf/hfq123. — View Citation
Nascimento BR, Lima MM, Nunes Mdo C, Alencar MC, Costa HS, Pinto Filho MM, Cota VE, Rocha MO, Ribeiro AL. Effects of exercise training on heart rate variability in Chagas heart disease. Arq Bras Cardiol. 2014 Sep;103(3):201-8. Epub 2014 Aug 1. English, Po — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional capacity | 12 weeks | No | |
Primary | Functional class | 12 weeks | No | |
Primary | Health related quality of life | 12 weeks | No | |
Primary | BNP levels | 12 weeks | No | |
Secondary | Complications related to the exercise training | 12 weeks | Yes |
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