Cardiac Contractility Modulation in Chagas Heart Disease
Recruiting · NCT05519046 · Interventional (participants receive a specific treatment) · Lead sponsor: InCor Heart Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 radical and safe contraceptive process),
- Previously withdrawn from this study.
Where it is running
1 location listed.
- InCor - HCFMUSP - São Paulo, São Paulo, Brazil