Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction

Not Applicable

• Conditions: Chagas Disease
• Interventions: Other: Exercise

• Registration Number: NCT02295215
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The prevalence of Chagas' disease continues high even in the developed countries. Chagasic Cardiomyopathy with preserved ventricular function is an understudied form of Chagas disease. Since a majority of patients with these changes progress to dilated form with ventricular dysfunction with all its serious consequences, it is interesting to better understand the pathophysiology of the disease at the stage where there electrocardiographic changes and preserved ventricular function. And besides, search strategies to slow the progress, or even prevent the chronic phase of the disease. For this reason the investigators will evaluate the effects of exercise training in patients with Chagas cardiomyopathy without ventricular dysfunction.

Detailed Description

Chagasic Cardiomyopathy with preserved ventricular function is an understudied form of Chagas disease. Since a majority of patients with these changes progress to dilated form with ventricular dysfunction with all its serious consequences, it is interesting to better understand the pathophysiology of the disease at the stage where there electrocardiographic changes and preserved ventricular function. And besides, search strategies to slow the progress, or even prevent the chronic phase of the disease. For this reason the investigators will evaluate the effects of exercise training in patients with Chagas cardiomyopathy without ventricular dysfunction.

Study Timeline

• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Chagas' disease patients, diagnosed with at least two positive serological reactions to Chagas' disease,
• Ejection fraction ≥55%

Exclusion Criteria

• Participation in a regular exercise program in the last 3 months preceding the survey
• Use of oral anticoagulant
• Use of a pacemaker or implantable cardioverter
• Hemodynamic instability
• Myocardial revascularization infarction or unstable angina in the last 3 months of the start of the protocol
• Diabetes mellitus
• Hypertension
• Pulmonary Disease
• Valvular lesions
• Atrial Fibrillation
• Angina of effort

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trained Group	Exercise	The patients will do exercise training for sixteen weeks.

Primary Outcome Measures

Name	Time	Method
Sympathetic nerve activityAutonomic control	4 months	Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle strength	4 months	Exercise training will increase skeletal muscle strength
Peak oxygen consumption	4 months	Exercise training will improve peak oxygen consumption

Trial Locations

Locations (1)

Heart Institute - HC-FMUSP; 🇧🇷 Sao Paulo, SP, Brazil