Cardiac Mechanics by Speckle Tracking as a Prognostic Predictor in Patients With Chagas Cardiomyopathy

NCT06806722 | Completed

• 2 other identifiers: 40088920.9.3001.006840088920.9.0000.0026
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Chagas Cardiomyopathy; Speckle Tracking; Global Longitudinal Strain; Mechanical Dispersion; Echocardiography; Heart Failure; Prognostic Markers; Chagas Disease

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality and Heart Failure Hospitalization

  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 Outcomes (4)

• Sudden Cardiac Death

  24 months from the date of enrollment.

• Sustained Ventricular Tachycardia

  24 months from the date of enrollment.

• Embolic Events

  24 months from the date of enrollment.

• Persistent Atrial Fibrillation

  24 months from the date of enrollment.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Instituto de Cardiologia do Distrito Federal: collaborator

Study Sites (1)

Instituto de Cardiologia do DF

Brasília, Federal District, 70675-731, Brazil

Location

Related Publications (2)

• Carluccio E, Biagioli P, Lauciello R, Zuchi C, Mengoni A, Bardelli G, Alunni G, Gronda EG, Ambrosio G. Superior Prognostic Value of Right Ventricular Free Wall Compared to Global Longitudinal Strain in Patients With Heart Failure. J Am Soc Echocardiogr. 2019 Jul;32(7):836-844.e1. doi: 10.1016/j.echo.2019.02.011. Epub 2019 Apr 9.

  PMID: 30979539 BACKGROUND

• Azevedo ACA, Barros MVL, Klaboe LG, Edvardsen T, Costa HS, Paixao GMM, Junior ORS, Nunes MCP, Rocha MOC. Association between myocardial mechanical dispersion and ventricular arrhythmogenicity in chagas cardiomyopathy. Int J Cardiovasc Imaging. 2021 Sep;37(9):2727-2734. doi: 10.1007/s10554-021-02246-8. Epub 2021 Apr 21.

  PMID: 33881664 BACKGROUND

MeSH Terms

Conditions

Chagas Cardiomyopathy; Death, Sudden; Heart Failure; Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Echocardiography Specialist, Institute of Cardiology of the Federal District.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: January 16, 2021
• Primary Completion: April 14, 2024
• Study Completion: April 16, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)