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

January 28, 2025 updated by: Luiz Carlos Madruga Ribeiro, University of Sao Paulo

Evaluation of Cardiac Mechanics by Speckle Tracking As a Prognostic Tool in Patients with Chagas Cardiomyopathy

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Federal District
      • Brasilia, Federal District, Brazil, 70675-731
        • Instituto de Cardiologia do DF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of patients with confirmed Chagas cardiomyopathy (CCM) and reduced left ventricular ejection fraction (≤50%) who are clinically stable and receiving outpatient care. Participants will be recruited consecutively from cardiology clinics in the Federal District and surrounding areas. Eligibility criteria ensure a focus on individuals at higher risk of adverse cardiovascular events, while exclusions aim to eliminate confounding factors such as severe comorbidities or inadequate imaging quality. The population represents a cohort of adults aged 18-70 years with confirmed Chagas disease, reflecting the demographic most affected by this condition.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1 - Cross Sectional
Patients with an implantable cardioverter defibrillator (ICD) for secondary prevention.
Group 2 - Cross Sectional
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
This cohort includes all patients from the cross-sectional phase, who will be prospectively followed for 24 months to evaluate clinical outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality and Heart Failure Hospitalization
Time Frame: 24 months from the date of enrollment
The primary outcome measure is a composite endpoint of all-cause mortality and hospitalization due to heart failure over a 24-month follow-up period. Mortality will include any death, regardless of cause. Hospitalization due to heart failure will be defined as an unplanned admission with a primary diagnosis of heart failure requiring intravenous diuretics, inotropic support, or other specialized management for decompensation. These events will be assessed using medical records, patient reports, or direct contact with healthcare providers.
24 months from the date of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sudden Cardiac Death
Time Frame: 24 months from the date of enrollment.
Sudden cardiac death will be defined as death occurring within one hour of symptom onset or when the individual was last seen in stable health within 24 hours prior to death. Events will be confirmed through medical records, autopsy reports, or witness statements.
24 months from the date of enrollment.
Sustained Ventricular Tachycardia
Time Frame: 24 months from the date of enrollment.
ustained ventricular tachycardia will be defined as a ventricular rhythm lasting 30 seconds or more, or requiring termination due to hemodynamic instability. Episodes will be confirmed using ICD/device reports or electrocardiographic documentation.
24 months from the date of enrollment.
Embolic Events
Time Frame: 24 months from the date of enrollment.
Embolic events will include confirmed cases of stroke, transient ischemic attack, or systemic embolism as documented by imaging studies or clinical reports.
24 months from the date of enrollment.
Persistent Atrial Fibrillation
Time Frame: 24 months from the date of enrollment.
Persistent atrial fibrillation will be defined as continuous atrial fibrillation lasting more than 7 days or requiring medical or electrical cardioversion. Diagnoses will be confirmed through electrocardiographic or device reports.
24 months from the date of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Instituto de Cardiologia do Distrito Federal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2021

Primary Completion (Actual)

April 14, 2024

Study Completion (Actual)

April 16, 2024

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40088920.9.3001.0068
  • 40088920.9.0000.0026 (Other Identifier: CAAE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly to ensure participant confidentiality and privacy Data will be analyzed and reported in aggregate form only, in accordance with ethical guidelines and participant consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chagas Cardiomyopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe