Clinical trial NCT01006473: Exercise Training in Chagas Cardiomyopathy
Official title: A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chagas Disease
Cardiomyopathy
Exercise Training
Keywords: Chagas Disease
Chagas Cardiomyopathy
Exercise Movement Techniques
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional capacity
timeFrame: 12 weeks
measure: Functional class
timeFrame: 12 weeks
measure: Health related quality of life
timeFrame: 12 weeks
measure: BNP levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Complications related to the exercise training
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Antonio L Ribeiro, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University if Minas Gerais
name: Manoel Otávio C Rocha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Maria do Carmo P Nunes, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.ijcard.2012.11.055. Epub 2012 Dec 8. No abstract available.
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 16.
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. doi: 10.5935/abc.20140108. Epub 2014 Aug 1.