Clinical trial NCT02295215: Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction
Official title: Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chagas Disease
Keywords: chagas disease
exercise
baroreflex sensitivity
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sympathetic nerve activityAutonomic control
timeFrame: 4 months
Secondary outcomes:
measure: Peak oxygen consumption
timeFrame: 4 months
measure: Skeletal muscle strength
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute - HC-FMUSP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Adriana O Sarmento
role: PRINCIPAL_INVESTIGATOR
References:
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.