NCT06806722Completed
Cardiac Mechanics by Speckle Tracking as a Prognostic Predictor in Patients With Chagas Cardiomyopathy
Evaluation of Cardiac Mechanics by Speckle Tracking as a Prognostic Tool in Patients With Chagas Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 4 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 153 (actual)
- First submitted
- 28 Jan 2025
- Start date
- 16 Jan 2021
- Primary completion date
- 14 Apr 2024
- Lead sponsor
- University of Sao Paulo
- Diseases
- Heart failure
- NCT number
- NCT06806722
What you commit to
- Study type: Observational
- Participants enrolled: 153
- From 16 Jan 2021 to the primary completion date, 14 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant coronary artery disease
- End-stage heart failure (Stage D)
- Severe systemic hypertension
- Life expectancy \<1 year due to other conditions
Other
- Ischemic cardiomyopathy
- Primary moderate or severe valvular lesions
- Inadequate echocardiographic window
- Persistent atrial fibrillation or flutter
- BMI \<18 kg/m² or alcohol consumption \>80 g/day
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Cardiologia do DF Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.