An observational study in Chagas Cardiomyopathy, Speckle Tracking Echocardiography and Arrythmias, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by University of Sao Paulo · Observational
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.
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.
17 studies on the registry are indexed under Chagas Cardiomyopathy; 2 are open to participants now.
Browse Chagas Cardiomyopathy studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an implantable cardioverter defibrillator (ICD) for secondary prevention.
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.
This cohort includes all patients from the cross-sectional phase, who will be prospectively followed for 24 months to evaluate clinical outcomes.
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.
Time frame: 24 months from the date of enrollment
Sudden Cardiac Death
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.
Time frame: 24 months from the date of enrollment.
Sustained Ventricular Tachycardia
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.
Time frame: 24 months from the date of enrollment.
Embolic Events
Embolic events will include confirmed cases of stroke, transient ischemic attack, or systemic embolism as documented by imaging studies or clinical reports.
Time frame: 24 months from the date of enrollment.
Persistent Atrial Fibrillation
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.
Time frame: 24 months from the date of enrollment.
Plan to share: No — 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.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.