RecruitingNot ApplicableNCT05519046

Cardiac Contractility Modulation in Chagas Heart Disease

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

Sponsor

InCor Heart Institute

Enrollment

60 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure Systolic Dysfunction Chagas Cardiomyopathy Right Bundle Branch Block and Left Anterior Fascicular Block Right Bundle Branch Block and Left Posterior Fascicular Block

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called Cardiac Contractility Modulation (CCM) — which delivers small electrical signals to the heart — in patients with heart failure caused by Chagas disease (a parasitic infection common in Latin America) to see if it can improve heart function. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of Chagas disease (two positive blood tests in the past 2 years) - You have heart failure with moderate symptoms (NYHA class II or III) - Your heart's pumping function is significantly reduced (ejection fraction below 35%) - You do not have a left bundle branch block - You have specific heart rhythm and strain findings on testing **You may NOT be eligible if...** - You have other significant heart conditions or uncontrolled diabetes with organ damage - You have significant kidney or liver disease - You have moderate to severe lung disease - You have nerve problems (peripheral polyneuropathy) or thyroid overactivity - You have alcoholism or drug addiction - You are pregnant or may become pregnant - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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