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Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05519046

Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease a Randomized Study comparing CCM and CRT devices

Led by InCor Heart Institute · Updated on 2025-04-04

60

Participants Needed

1

Research Sites

N/A

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 a widespread condition in Latin America caused by the parasite Trypanosoma cruzi, affecting millions and leading to chronic Chagas cardiomyopathy CCC in 30-50 of cases. This serious heart condition often results in heart failure and high rates of illness and death. The trial investigates whether cardiac contractility modulation CCM devices provide better clinical and functional benefits compared to cardiac resynchronization therapy CRT for patients with advanced heart failure and CCC who do not have left bundle branch block. The study involves two groups one receiving CCM device implantation and the other undergoing CRT implantation. CCM delivers high-tension electrical stimulation to improve heart muscle contraction during a specific phase of the heartbeat. The trial compares these two device-based treatments to evaluate their impact on heart function and patient quality of life. Participants will be monitored over six months with assessments including quality of life scores, heart strain measurements, functional capacity tests like the 6-minute walk test, heart failure classification, and hospitalization records. The study tracks these measures at the start and after six months to determine the effects of the treatments on heart performance and daily functioning in patients with CCC and severe heart failure.

CONDITIONS

Brief Title

Cardiac Contractility Modulation in Chagas Heart Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • Both men and women aged over 18 and under 75 years
  • Positive documented serology for Chagas disease within the last two years confirmed by at least two tests
  • Heart failure classified as NYHA functional class II or III
  • Left ventricular ejection fraction below 35%
  • Absence of left bundle branch block
  • Presence of intraventricular desynchrony (Yu index)
  • Global longitudinal strain greater than 11%
Not Eligible

You will not qualify if you...

  • Participation in another study currently or within the past year, except unrelated observational studies
  • Other cardiovascular diseases or 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 including cirrhosis, portal hypertension, or elevated liver enzymes more than three times normal
  • Moderate or severe chronic obstructive pulmonary disease
  • Peripheral polyneuropathy
  • Hyperthyroidism
  • Current alcoholism or not abstinent for over 2 years
  • Diagnosed psychopathy, psychosis, or addiction to illicit drugs
  • Life expectancy less than 1 year due to disease or comorbidities, including NYHA class IV
  • Pregnancy or breastfeeding
  • Potential to become pregnant during the study without safe contraception
  • Previous withdrawal from this study

Research Team

M

Martino Martinelli Filho, PhD

S

Sergio F Siqueira, MsC

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