Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction

Chagas Disease Clinical Trial

— CH0660/10  

Official title:

Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295215
• Other study ID #: NCT01900000
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: November 14, 2014
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: University of Sao Paulo General Hospital
• Contact: Carlos E Negrão
• Phone: 5511 26615699
• Email: cndnegrao[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chagas Disease
• Ventricular Dysfunction

Intervention

Other:
• Exercise
Exercise Training for 4 months

Locations

Country	Name	City	State
Brazil	Heart Institute - HC-FMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic nerve activityAutonomic control	Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.	4 months	No
Secondary	Peak oxygen consumption	Exercise training will improve peak oxygen consumption	4 months	No
Secondary	Skeletal muscle strength	Exercise training will increase skeletal muscle strength	4 months	No