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

November 14, 2014 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
        • Recruiting
        • Heart Institute - HC-FMUSP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Sedentary Group
The patients will not do exercise training
EXPERIMENTAL: Trained Group
The patients will do exercise training for sixteen weeks.
Other: Exercise
Exercise Training for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sympathetic nerve activityAutonomic control
Time Frame: 4 months
Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen consumption
Time Frame: 4 months
Exercise training will improve peak oxygen consumption
4 months
Skeletal muscle strength
Time Frame: 4 months
Exercise training will increase skeletal muscle strength
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Adriana O Sarmento, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (ESTIMATE)

November 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01900000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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