Cardiac Mechanics by Speckle Tracking As a Prognostic Predictor in Patients with Chagas Cardiomyopathy (ST-Chagas)

University of Sao Paulo

Status: Completed

Conditions: Chagas Cardiomyopathy; Speckle Tracking Echocardiography; Arrythmias; ICD; Sudden Death

Study type: Observational

Funder types: Other

Identifiers

NCT06806722

40088920.9.3001.0068

40088920.9.0000.0026 (Other Identifier)

Details and patient eligibility

About

This study aims to evaluate the prognostic value of myocardial mechanics parameters, including global longitudinal strain (GLS) and mechanical dispersion (MD), assessed through speckle tracking echocardiography, in patients with Chagas cardiomyopathy (CCM). The study is divided into two arms: a cross-sectional arm and a longitudinal arm. The cross-sectional arm compares echocardiographic parameters between patients with and without implantable cardioverter defibrillators (ICD) for secondary prevention. The longitudinal arm assesses clinical outcomes over 24 months. Primary outcomes include all-cause mortality and hospitalization due to heart failure, while secondary outcomes encompass sudden cardiac death, sustained ventricular tachycardia, embolic events, and persistent atrial fibrillation.

Full description

The study is divided into two phases:

Cross-sectional phase: Patients with CCM and LV ejection fraction (LVEF) ≤50% will be categorized into two groups based on the presence or absence of an ICD for secondary prevention. GLS and MD parameters will be evaluated to determine their association with higher-risk patients.

Longitudinal phase: Patients from the cross-sectional phase will be followed for 24 months to assess primary outcomes (all-cause mortality and heart failure hospitalization) and secondary outcomes (sudden cardiac death, sustained ventricular tachycardia, embolic events, and persistent atrial fibrillation). Prognostic utility of GLS and MD will be compared with traditional parameters.

Study Design:

Study Type: Observational

Estimated Enrollment: 153 participants

Observational Model: Cohort

Time Perspective: Prospective

Study Start Date: [To be added]

Primary Completion Date: [To be added]

Study Completion Date: [To be added]

Outcome Measures:

Primary Outcome Measures:

All-cause mortality (Time Frame: 24 months)

Hospitalization due to heart failure (Time Frame: 24 months)

Secondary Outcome Measures:

Sudden cardiac death (Time Frame: 24 months)

Sustained ventricular tachycardia (Time Frame: 24 months)

Embolic events (Time Frame: 24 months)

Persistent atrial fibrillation (Time Frame: 24 months)

Eligibility Criteria:

Inclusion Criteria:

Age 18-70 years

Diagnosed Chagas disease confirmed by two serological tests

LVEF ≤50% (Simpson's method)

Clinically stable for at least three months

Sinus rhythm or paced atrial rhythm on ECG

Signed informed consent

Exclusion Criteria:

Significant coronary artery disease

End-stage heart failure (Stage D)

Ischemic cardiomyopathy

Severe systemic hypertension

Primary moderate or severe valvular lesions

Inadequate echocardiographic window

Persistent atrial fibrillation or flutter

BMI <18 kg/m² or alcohol consumption >80 g/day

Life expectancy <1 year due to other conditions

Study Arms:

Cross-sectional Group:

Group 1: CCM patients with ICD (high-risk group)

Group 2: CCM patients without ICD

Longitudinal Group:

All patients followed for outcomes.

Statistical Analysis:

Normality of quantitative variables will be tested using the Kolmogorov-Smirnov test.

Differences between groups analyzed using t-tests, Mann-Whitney tests, chi-square tests, or Fisher's exact tests.

Multivariable Cox proportional hazards models will assess predictors of high-risk outcomes.

Kaplan-Meier survival analysis will estimate event-free survival rates.

Sponsor and Collaborators:

Sponsor: Institute of Cardiology, Federal District, Brazil

Collaborators:

Heart Institute (InCor) - University of São Paulo

Santa Lúcia South Hospital

Principal Investigators:

Dr. Luiz Carlos Madruga Ribeiro

Dr. Ludhmila Abrahão Hajjar

Dr. Adenalva Lima de Souza Beck

Funding Source:

Self-funded (Estimated total cost: BRL 8,200)

Ethical Considerations:

Approved by the ethics committee of ICDF.

Confidentiality and participant safety are prioritized.

Echocardiograms performed by trained physicians.

Enrollment: 153 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years
• Diagnosed Chagas disease confirmed by two serological tests
• LVEF ≤50% (Simpson's method)
• Clinically stable for at least three months
• Sinus rhythm or paced atrial rhythm on ECG
• Signed informed consent

Exclusion criteria

• Significant coronary artery disease
• End-stage heart failure (Stage D)
• Ischemic cardiomyopathy
• Severe systemic hypertension
• Primary moderate or severe valvular lesions
• Inadequate echocardiographic window
• Persistent atrial fibrillation or flutter
• BMI <18 kg/m² or alcohol consumption >80 g/day
• Life expectancy <1 year due to other conditions

Trial design

153 participants in 3 patient groups

Group 1 - Cross Sectional

Description:

Patients with an implantable cardioverter defibrillator (ICD) for secondary prevention.

Group 2 - Cross Sectional

Description:

atients without an ICD and no history of severe arrhythmic events. The purpose of this arm is to compare echocardiographic parameters, such as global longitudinal strain (GLS) and mechanical dispersion (MD), between high-risk and lower-risk patients.

Longitudinal Cohort

Description:

This cohort includes all patients from the cross-sectional phase, who will be prospectively followed for 24 months to evaluate clinical outcomes.