Cardiac Contractility Modulation in Chagas Heart Disease

Launched by INCOR HEART INSTITUTE · Aug 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called cardiac contractility modulation (CCM) for patients with Chagas cardiomyopathy, a heart condition caused by a parasite that can lead to heart failure. The researchers want to find out if patients with severe heart failure and specific heart rhythm issues will have better health outcomes when they receive a CCM device compared to a different treatment known as cardiac resynchronization therapy. This study is important because many current treatments for heart failure in Chagas disease have not been very effective.

To be eligible for the trial, participants need to be between 18 and 75 years old, have a recent positive test for Chagas disease, and be classified as having moderate to severe heart failure. Key factors include having a weakened heart function (with a specific measurement below 35%) and not having certain heart rhythm problems. Participants who join the study will receive the CCM device and will be monitored to see how well it helps their heart function and overall health. This trial is currently recruiting participants, and it is essential for potential volunteers to discuss their individual health conditions with their doctors to see if they qualify.

Gender

ALL

Eligibility criteria

• 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.