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

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ClinicalTrials.gov Identifier: NCT02295215
Recruitment Status : Unknown
Verified June 2013 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chagas Disease Other: Exercise Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction
Study Start Date : June 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sympathetic nerve activityAutonomic control [ Time Frame: 4 months ]
    Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.


Secondary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 4 months ]
    Exercise training will improve peak oxygen consumption

  2. Skeletal muscle strength [ Time Frame: 4 months ]
    Exercise training will increase skeletal muscle strength



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295215


Contacts
Contact: Carlos E Negrão 5511 26615699 cndnegrao@incor.usp.br
Contact: Adriana S Oliveira 5511 26615057 adriana.sarmento@usp.br

Locations
Brazil
Heart Institute - HC-FMUSP Recruiting
Sao Paulo, SP, Brazil, 05403-900
Contact: Adriana S Oliveira    5511 26615057    adriana.sarmento@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Adriana O Sarmento University of Sao Paulo General Hospital

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02295215     History of Changes
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: June 2013

Keywords provided by University of Sao Paulo General Hospital:
chagas disease
exercise
baroreflex sensitivity

Additional relevant MeSH terms:
Ventricular Dysfunction
Chagas Disease
Heart Diseases
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases