Trypanosomiasis
Conditions
Interventions
This is an observational study. A group of 210 patients with Chagas Cardiomyopathy, 70 with ventricular dysfunction and 140 without ventricular dysfunction, with the objective of verifying whether the
V03.175.500
Sponsors
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares - PROCAPE
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares - PROCAPE
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants diagnosed with Chagas cardiomyopathy, with reactive serology by two different serological methods (indirect immunofluorescence, indirect hemagglutination, complement fixation, conventional ELISA and recombinant ELISA immunoassay), with and without left ventricular dysfunction, as determined by transthoracic echocardiography; age 18 years or older up to 80 years or younger; both sexes; provision of written, signed and dated Informed Consent Form
Exclusion criteria
Exclusion criteria: Individuals with Trypanosoma cruzi infection in the absence of clinical manifestations and signs of cardiac involvement as characterized by normal electrocardiogram, chest X-ray, and echocardiogram; history or current diagnosis of malignant neoplasia; chronic use of corticosteroids, anti-inflammatory drugs, or immunosuppressants; patients with pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization devices, metal clips for aneurysms, or other metallic implants that may contraindicate MRI; individuals with known coronary artery disease (CAD) (acute myocardial infarction, unstable angina, history of myocardial revascularization or angioplasty, and documented coronary obstruction by catheterization or coronary CT angiography); research participants who have participated in clinical trial protocols within the last 12 months, unless the investigator determines potential direct benefit (per CNS Resolution 251, August 7, 1997, Section III, Subitem J); alcohol and substance abuse (prior diagnosis according to DSM-V criteria); illicit drug use; any clinical condition that the investigating physician interprets as a risk to participant inclusion; claustrophobic participants unwilling to take the study-prescribed anxiolytic (Rivotril 0.25 mg); patients with tachyarrhythmia if decompensated at MRI time; pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistical correlation between TIMP-1 and clinical progression in Chronic Chagasic Cardiomyopathy over 18 months of trial follow-up, analyzed with parametric tests for Gaussian-distributed samples or non-parametric tests for non-normal distributions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate plasma TIMP-1 levels in participants diagnosed with Chagas cardiomyopathy with and without ventricular dysfunction over an 18-month follow-up period;Determine the correlation between plasma TIMP-1 levels and left ventricular systolic function, assessed by transthoracic echocardiography and cardiac magnetic resonance imaging (MRI), at baseline and after 18 months of follow-up;Determine the correlation between plasma TIMP-1 and NT-proBNP levels at baseline and after 18 months;Determine the correlation between plasma TIMP-1 levels and global longitudinal strain (GLS) at baseline and at 18-month follow-up;Correlate global longitudinal strain (GLS) with myocardial fibrosis (assessed by cardiac MRI) and ejection fraction (assessed by transthoracic echocardiography) throughout the 18-month period;Collect and store participant blood samples to establish a biorepository for future development of a prognostic test for Chagas disease;Perform metabolomic analysis of participant blood samples;Evaluate the immune/inflammatory response in Chagas disease | — |
Countries
Brazil
Contacts
Public ContactSilvia Martins
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares - PROCAPE
Outcome results
None listed