Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction (CH0660/10)
Primary Purpose
Chagas Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chagas Disease focused on measuring chagas disease, exercise, baroreflex sensitivity
Eligibility 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
Sites / Locations
- Heart Institute - HC-FMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Sedentary Group
Trained Group
Arm Description
The patients will not do exercise training
The patients will do exercise training for sixteen weeks.
Outcomes
Primary Outcome Measures
Sympathetic nerve activityAutonomic control
Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.
Secondary Outcome Measures
Peak oxygen consumption
Exercise training will improve peak oxygen consumption
Skeletal muscle strength
Exercise training will increase skeletal muscle strength
Full Information
NCT ID
NCT02295215
First Posted
August 25, 2014
Last Updated
November 14, 2014
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02295215
Brief Title
Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction
Acronym
CH0660/10
Official Title
Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease
Keywords
chagas disease, exercise, baroreflex sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sedentary Group
Arm Type
No Intervention
Arm Description
The patients will not do exercise training
Arm Title
Trained Group
Arm Type
Experimental
Arm Description
The patients will do exercise training for sixteen weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise Training for 4 months
Primary Outcome Measure Information:
Title
Sympathetic nerve activityAutonomic control
Description
Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Peak oxygen consumption
Description
Exercise training will improve peak oxygen consumption
Time Frame
4 months
Title
Skeletal muscle strength
Description
Exercise training will increase skeletal muscle strength
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos E Negrão
Phone
5511 26615699
Email
cndnegrao@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana S Oliveira
Phone
5511 26615057
Email
adriana.sarmento@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana O Sarmento
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute - HC-FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana S Oliveira
Phone
5511 26615057
Email
adriana.sarmento@usp.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
32875456
Citation
Sarmento AO, Antunes-Correa LM, Alves MJNN, Bacurau AVN, Fonseca KCB, Pessoa FG, Lobo DML, Moreira LDP, Trombetta IC, Rondon MUPB, Rondon E, Vieira MLC, Ramires FJA, do Brasileiro-Santos MS, Brum PC, Mady C, Negrao CE, Thomas S, Ianni BM. Effect of exercise training on cardiovascular autonomic and muscular function in subclinical Chagas cardiomyopathy: a randomized controlled trial. Clin Auton Res. 2021 Apr;31(2):239-251. doi: 10.1007/s10286-020-00721-1. Epub 2020 Sep 1.
Results Reference
derived
Learn more about this trial
Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction
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