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Heart device showdown: could CCM beat CRT for chagas patients?

NCT ID NCT05519046

Disease control Sponsor: InCor Heart Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study compares two implantable heart devices—Cardiac Contractility Modulation (CCM) and Cardiac Resynchronization Therapy (CRT)—in people with Chagas heart disease and advanced heart failure. The goal is to see which device better improves quality of life and heart function. Participants must have Chagas infection, severe heart failure, and a specific heart rhythm pattern.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cardiac Contractility Modulation (CCM) device
What this could lead to
If CCM works better than CRT, it could offer a new treatment option for people with Chagas-related heart failure who do not benefit from standard therapy.
What could go wrong
This is a small, early-stage study with only 60 participants, so results may not apply to everyone. Devices carry risks like infection or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 %. Exclusion Criteria: * 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, * Peripheral polyneuropathy, * Hyperthyroidism, * Current alcoholism or not abandoned for \>2 years, * Diagnosed with psychopathy or psychosis or addiction to illicit drugs, * Life expectancy \<1 year, due to the disease itself or comorbidities (including NYHA class IV), * Pregnancy or breastfeeding, * Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process), * Previously withdrawn from this study.

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Conditions

The condition(s) this trial relates to.

bundle branch block, familial isolated complete right Chagas cardiomyopathy heart failure progressive familial heart block, type 1A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chagas cardiomyopathy Heart failure Right bundle branch block and left anterior fascicular block Right bundle branch block and left posterior fascicular block Systolic dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • InCor - HCFMUSP

    RECRUITING

    São Paulo, São Paulo, 05403-900, Brazil

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