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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Signing of an informed consent form (ICF) before randomization and any study procedure,

• Both genders, age \>18 years and \<75 years,

• Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),

• NYHA II-III heart failure functional class,

• LVEF\< 35%,

• Non left bundle branch block

• Intraventricular desynchrony (Yu index)

• Global longitudinal strain \>11 %.

Locations
Other Locations
Brazil
InCor - HCFMUSP
RECRUITING
São Paulo
Contact Information
Primary
Martino Martinelli Filho, PhD
martino@incor.usp.br
+551126615515
Backup
Sergio F Siqueira, MsC
sergio.siqueira@hc.fm.usp.br
+551126615514
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Cardiac Contractility Modulation Group - CCM Group
CCM implantation.
Active_comparator: Cardiac Resynchronization Therapy Group - CRT Group
CRT implantation
Sponsors
Leads: InCor Heart Institute
Collaborators: I2medi Comercial Medica LTDA, Impulse Dynamics

This content was sourced from clinicaltrials.gov

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