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Clinical Trials/NCT01006473
NCT01006473
Completed
Phase 4

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

Federal University of Minas Gerais1 site in 1 country37 target enrollmentMarch 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Chagas Disease
Sponsor
Federal University of Minas Gerais
Enrollment
37
Locations
1
Primary Endpoint
Health related quality of life
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
March 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Minas Gerais
Responsible Party
Principal Investigator
Principal Investigator

Antonio Luiz Pinho Ribeiro

Professor

Federal University of Minas Gerais

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

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: 12 weeks

Functional class

Time Frame: 12 weeks

Functional capacity

Time Frame: 12 weeks

BNP levels

Time Frame: 12 weeks

Secondary Outcomes

  • Complications related to the exercise training(12 weeks)

Study Sites (1)

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