Device Therapy Tested for Heart Failure Caused by Chagas Disease
Compares a contractility device with resynchronization therapy in people with Chagas heart failure.
Plain-language title generated from the registry record
Registry title: Cardiac Contractility Modulation in Chagas Heart Disease
Key facts
- Where
- São Paulo, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05519046, who can take part
Where in Brazil
- InCor HCFMUSPSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- InCor Heart Institute
- Trial code
- NCT05519046
- Record updated
- 8 July 2026
- Original description
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.Read full original descriptionShow less
Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas
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.
Inclusion: 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 %.
Exclusion: 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; Moderate or severe chronic obstructive pulmonary disease,; Life expectancy <1 year, due to the disease itself or comorbidities (including NYHA class IV),; 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,; Current alcoholism or not abandoned for >2 years,; 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),.