Chagas cardiomyopathy Chagas disease
Conditions
Interventions
This is a randomized, controlled, prospective, parallel-group, two-arm clinical trial with blinded outcome assessors. A total target sample of 34 participants (17 per group) will be enrolled. After ba
Sponsors
Escola de Educação Física, Fisioterapia e Terapia Ocupacional (EEFFTO) da Universidade Federal de Minas Gerais (UFMG)
Hospital de Clínicas (HC) da Universidade Federal do Triângulo Mineiro (UFTM)
Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults (aged 18 years or older); both sexes; confirmed Chagas disease based on two distinct serological tests (e.g., indirect immunofluorescence, enzyme-linked immunosorbent assay (ELISA), or hemagglutination); evidence of myocardial involvement defined by segmental or global systolic dysfunction on echocardiography or by electrocardiographic abnormalities suggestive of Chagas cardiomyopathy; left ventricular ejection fraction (LVEF) higher than 40%; New York Heart Association (NYHA) functional class I or II; recruitment at the Chagas disease outpatient clinic at the Hospital das Clínicas of the Federal University of Minas Gerais (UFMG) and at participating centers of the Federal University of Triângulo Mineiro (UFTM) and the Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM)
Exclusion criteria
Exclusion criteria: Patients presenting with another etiology for myocardial dysfunction, such as alcoholism, previous myocardial infarction, known coronary artery disease, use of cardiotoxic agents or illicit drugs, peripartum cardiomyopathy, primary valvular heart disease, and pericardial disease, will be excluded. Patients with comorbidities that impair functional capacity, such as Chronic obstructive pulmonary disease (COPD) severe, severe liver disease, collagen vascular disease, and untreated thyroid dysfunction, will also be excluded. Coronary artery disease (CAD) must be ruled out by cardiac catheterization in patients who present ischemic perfusion defects on myocardial perfusion scintigraphy and have three or more risk factors for atherosclerotic coronary artery disease. Finally, individuals presenting physical limitations (orthopedic or neurological) to aerobic exercise on a treadmill and/or walking, or any contraindication to moderate-intensity aerobic physical activity, will also be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the assessment of functional capacity observed through the cardiopulmonary exercise test (maximum oxygen consumption) and the Shuttle test (distance covered) based on the proposed semi-supervised rehabilitation program. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in global left ventricular systolic function, assessed by left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS), as well as changes in regional left ventricular function, assessed by segmental strain on echocardiography ; Changes in autonomic balance, assessed by heart rate variability, including sympathetic and parasympathetic activity;Changes in functional capacity, assessed by cardiopulmonary exercise testing, including oxygen uptake at the anaerobic threshold, the VE/VCO2 slope; The Shuttle Walk Test, expressed as the percentage of the predicted distance;The handgrip strength test, as a measure of overall muscle strength;The 1-minute sit-to-stand test, as a measure of lower-limb strength and endurance;the Glittre ADL test, for the assessment of activities of daily living;Changes in quality of life, assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) | — |
Countries
BR
Contacts
Public ContactIgor Almeida
Universidade Federal de Minas Gerais
Outcome results
None listed