Exercise Training in Chagas Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006473
• Other study ID #: CNPq402024/2005-2
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Chagas Cardiomyopathy
• Chagas Disease
• Exercise Training

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