RecruitingNot Applicable

Cardiac Contractility Modulation in Chagas Heart Disease

Brazil60 participantsStarted 2022-05-25

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Participation in another study, presently or terminated \<1 year ago, except for a totally unrelated observational study, * Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise), * 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, * Moderate or severe chronic obstructive pulmonary disease, * Peripheral polyneuropathy, * Hyperthyroidism, * Current alcoholism or not abandoned for \>2 years, * Diagnosed with psychopathy or psychosis or addiction to illicit drugs, * Life expectancy \<1 year, due to the disease itself or comorbidities (including NYHA class IV), * Pregnancy or breastfeeding, * Potential to become pregnant during the study (non-menopausal patients who have not undergone a …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

QoL Score

Timeframe: At baseline

QoL Score

Timeframe: At 6 months

GLS

Timeframe: At baseline

GLS

Timeframe: At 6 months

Trial details

NCT IDNCT05519046

SponsorInCor Heart Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Martino Martinelli Filho, PhD

+551126615515 martino@incor.usp.br

View on ClinicalTrials.gov More Chagas Cardiomyopathy trials