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RECRUITING
NCT05519046
NA

Cardiac Contractility Modulation in Chagas Heart Disease

Sponsor: InCor Heart Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-05-25

Completion Date

2026-12-31

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DEVICE

Cardiac Contractility Modulation (CCM)

Cardiac Contractility Modulation (CCM) implantation

DEVICE

CRT

Cardiac Resynchronization Therapy

Locations (1)

InCor - HCFMUSP

São Paulo, São Paulo, Brazil