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Cardiac Contractility Modulation in Chagas Heart Disease

NCT05519046 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-04

No results posted yet for this study

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.

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

Interventions

DEVICE

Cardiac Contractility Modulation (CCM)

Cardiac Contractility Modulation (CCM) implantation

DEVICE

CRT

Cardiac Resynchronization Therapy

Sponsors & Collaborators

  • Impulse Dynamics

    collaborator INDUSTRY

  • I2medi Comercial Medica LTDA

    collaborator UNKNOWN

  • InCor Heart Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519046 on ClinicalTrials.gov