Chagas CardiomyopathyST-ChagasNCT06806722
Cardiac Mechanics by Speckle Tracking as a Prognostic Predictor in Patients With Chagas Cardiomyopathy
An observational study of Chagas Cardiomyopathy and Speckle Tracking Echocardiography, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Cardiomyopathy, Speckle Tracking Echocardiography, Arrythmias
- How many people
- 153 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2021to 16 Apr 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Significant coronary artery disease
- End-stage heart failure (Stage D)
- Ischemic cardiomyopathy
- Severe systemic hypertension
- Primary moderate or severe valvular lesions
- Inadequate echocardiographic window
Show all 9Show fewer
- Persistent atrial fibrillation or flutter
- BMI <18 kg/m² or alcohol consumption >80 g/day
- Life expectancy <1 year due to other conditions
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do DF
Brasília, Federal District, 70675-731
About this study
Official title: 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.
Read the 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.
- Keywords
- Chagas Cardiomyopathy, Speckle Tracking, Global Longitudinal Strain, Mechanical Dispersion, Echocardiography, Heart Failure, Prognostic Markers, Chagas Disease
- Medical subject headings
- Chagas Cardiomyopathy, Death, Sudden, Heart Failure, Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months from the date of enrollment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months from the date of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start16 Jan 2021
- Primary completion14 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chagas CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Cardiologia do Distrito Federal
- Responsible party
- Principal investigator, Luiz Carlos Madruga Ribeiro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806722
- Sponsor's protocol ID
- 40088920.9.3001.0068
- Other IDs
- 40088920.9.0000.0026
- Acronym
- ST-Chagas
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30979539Azevedo 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.
PubMed 33881664
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Mechanics by Speckle Tracking as a Prognostic Tool in Patients With Chagas Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06806722
- Acronym / sponsor ID
- ST-Chagas / 40088920.9.3001.0068
- Keywords
- Chagas Cardiomyopathy, Speckle Tracking, Global Longitudinal Strain, Mechanical Dispersion, Echocardiography, Heart Failure, Prognostic Markers, Chagas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Instituto de Cardiologia do Distrito Federal
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Significant coronary artery disease
- End-stage heart failure (Stage D)
- Ischemic cardiomyopathy
- Severe systemic hypertension
- Primary moderate or severe valvular lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Sudden Cardiac Death
Time frame: 24 months from the date of enrollment.
Sustained Ventricular Tachycardia
Time frame: 24 months from the date of enrollment.
Embolic Events
Time frame: 24 months from the date of enrollment.
Persistent Atrial Fibrillation
Time frame: 24 months from the date of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Results publication: PubMed 30979539Carluccio 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.
- Results publication: PubMed 33881664Azevedo 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.
- Individual participant dataSharing planned: 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.
Related trials for Chagas Cardiomyopathy
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Cardiac Contractility Modulation in Chagas Heart Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Cardiomyopathy and Speckle Tracking Echocardiography, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality and Heart Failure Hospitalization (time frame: 24 months from the date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.