Improving heart function in patients with Chagas disease
Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas
NA · InCor Heart Institute · NCT05519046
This study is testing whether a new heart treatment called cardiac contractility modulation can help people with heart failure from Chagas disease feel better compared to a different treatment called cardiac resynchronization therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | InCor Heart Institute (other) |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05519046 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of cardiac contractility modulation (CCM) as an adjuvant treatment for heart failure in patients suffering from chronic Chagas cardiomyopathy (CCC). It aims to compare the clinical and functional responses of patients receiving CCM device implantation against those undergoing cardiac resynchronization therapy (CRT). The study focuses on individuals with advanced heart failure, severe systolic dysfunction, and specific conduction patterns, utilizing a randomized approach to assess outcomes. The research is particularly relevant given the high prevalence of Chagas disease in Latin America and its emerging significance in other regions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with documented Chagas disease and advanced heart failure characterized by severe systolic dysfunction.
Not a fit: Patients with other significant cardiovascular diseases or those with kidney or liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that significantly improves heart function and quality of life for patients with Chagas disease.
How similar studies have performed: While there is limited evidence on the use of CCM specifically for CCC, similar approaches in heart failure management have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- InCor - HCFMUSP — São Paulo, São Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Martino Martinelli Filho, PhD
- Email: martino@incor.usp.br
- Phone: +551126615515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction, Right Bundle Branch Block and Left Anterior Fascicular Block, Right Bundle Branch Block and Left Posterior Fascicular Block