Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05519046 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Cardiac Contractility Modulation in Chagas Heart Disease

Study acronym: FIX-Chagas
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 31, 2026 to Dec 31, 2027v3
  2. Notable Primary and study completion dates: Dec 31, 2023 to Dec 31, 2026
    • Start date: May 6, 2022 to May 25, 2022
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05519046
Lead Sponsor InCor Heart Institute
Collaborators: Impulse Dynamics, I2medi Comercial Medica LTDA
Conditions
(from sponsor)
Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction, Right Bundle Branch Block and Left Anterior Fascicular Block, Right Bundle Branch Block and Left Posterior Fascicular Block
Related terms Bundle-Branch Block, Chagas Cardiomyopathy, Heart Failure
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov