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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006473
Other study ID # CNPq402024/2005-2
Secondary ID
Status Completed
Phase Phase 4
First received November 1, 2009
Last updated August 10, 2015
Start date March 2007
Est. completion date March 2009

Study information

Verified date August 2015
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Exercise training


Locations

Country Name City State
Brazil Federal University of Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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

Outcome

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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