Clinical trial NCT06806722: Cardiac Mechanics by Speckle Tracking as a Prognostic Predictor in Patients With Chagas Cardiomyopathy
Official title: Evaluation of Cardiac Mechanics by Speckle Tracking as a Prognostic Tool in Patients With Chagas Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto de Cardiologia do Distrito Federal
First posted: 2025-02-04
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: All-Cause Mortality and Heart Failure Hospitalization
timeFrame: 24 months from the date of enrollment
Secondary outcomes:
measure: Sudden Cardiac Death
timeFrame: 24 months from the date of enrollment.
measure: Sustained Ventricular Tachycardia
timeFrame: 24 months from the date of enrollment.
measure: Embolic Events
timeFrame: 24 months from the date of enrollment.
measure: Persistent Atrial Fibrillation
timeFrame: 24 months from the date of enrollment.
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Instituto de Cardiologia do DF
state: Federal District
Study officials:
References:
citation: 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.
citation: 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.