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.
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,
Participation in another study, presently or terminated <1 year ago, except for a totally unrelated observational study,
Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
Kidney dysfunction (serum creatinine >1.5mg/dL or eGFR <30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) > 3x the upper limit of normality,
Moderate or severe chronic obstructive pulmonary disease,
Parallel
Cardiac Contractility Modulation (CCM)
DeviceCardiac Contractility Modulation (CCM) implantation
CRT
DeviceCardiac Resynchronization Therapy
QoL Score
KCCQS - Kansas City cardiomyopathy quality score
QoL Score
KCCQS - Kansas City cardiomyopathy quality score
GLS
Global longitudinal strain at rest/effort - (tissue tracking)
GLS
Global longitudinal strain at rest/effort - (tissue tracking)
6MWT
6-minute walk test
6MWT
6-minute walk test
NYHAFC
HF functional class assessed as established by the NYHA
NYHAFC
HF functional class assessed as established by the NYHA
Click on the lead sponsor to view all of their trials.
InCor Heart Institute
Lead sponsor
Impulse Dynamics
Collaborator
I2medi Comercial Medica LTDA
Collaborator
