NCT05519046Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC. The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Aug 2022
- Start date
- 25 May 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- InCor Heart Institute
- Diseases
- Heart failure
- NCT number
- NCT05519046
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 May 2022 to the primary completion date, 31 Dec 2027
- 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.
Prior treatment
- Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
- Diagnosed with psychopathy or psychosis or addiction to illicit drugs,
- Previously withdrawn from this study.
Other illness
- Moderate or severe chronic obstructive pulmonary disease,
- Life expectancy \<1 year, due to the disease itself or comorbidities (including NYHA class IV),
Lab values
- Kidney dysfunction (serum creatinine \>1.5mg/dL or eGFR \<30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) \> 3x the upper limit of normality,
Age
- Current alcoholism or not abandoned for \>2 years,
Other
- Participation in another study, presently or terminated \<1 year ago, except for a totally unrelated observational study,
- Peripheral polyneuropathy,
- Hyperthyroidism,
- Pregnancy or breastfeeding,
- Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process),
Who the study is looking for
- Signing of an informed consent form (ICF) before randomization and any study procedure,
- Both genders, age \>18 years and \<75 years,
- Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),
- NYHA II-III heart failure functional class,
- LVEF\< 35%,
- Non left bundle branch block
- Intraventricular desynchrony (Yu index)
- Global longitudinal strain \>11 %.
Age in the registry: 18 years to 75 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 |
|---|---|---|---|
| InCor HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.