Actively Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Led by InCor Heart Institute · Updated on 2025-04-04
60
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
I
InCor Heart Institute
Lead Sponsor
I
Impulse Dynamics
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Cardiac Contractility Modulation in Chagas Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before randomization and any study procedure
- Age over 18 years and under 75 years
- Both genders
- Recent positive serology for Chagas disease confirmed by at least two different tests within the last two years
- Heart failure functional class II or III by New York Heart Association classification
- Left ventricular ejection fraction below 35%
- No left bundle branch block
- Presence of intraventricular desynchrony (Yu index)
- Global longitudinal strain greater than 11%
You will not qualify if you...
- Participation in another study currently or within the last year, except for unrelated observational studies
- Other cardiovascular diseases, including uncontrolled diabetes mellitus
- Kidney dysfunction with serum creatinine above 1.5 mg/dL or estimated glomerular filtration rate below 30 mL/min/1.73m2
- Liver dysfunction such as cirrhosis, portal hypertension, or elevated liver enzymes above three times the normal limit
- Moderate or severe chronic obstructive pulmonary disease
- Peripheral polyneuropathy
- Hyperthyroidism
- Current alcoholism or alcoholism not abandoned for more than two years
- Diagnosed psychopathy, psychosis, or addiction to illicit drugs
- Life expectancy less than one year due to disease or comorbidities, including NYHA class IV
- Pregnancy or breastfeeding
- Potential to become pregnant during the study without safe contraceptive measures
- Previous withdrawal from this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
InCor - HCFMUSP
São Paulo, São Paulo, Brazil, 05403-900
Actively Recruiting
Research Team
M
Martino Martinelli Filho, PhD
CONTACT
S
Sergio F Siqueira, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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