Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction (CH0660/10)

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Chagas Disease

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02295215

NCT01900000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sedentary Group

No Intervention group

Description:

The patients will not do exercise training

Trained Group

Experimental group

Description:

The patients will do exercise training for sixteen weeks.

Treatment:

Other: Exercise