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Can cutting nerves stop deadly heart rhythms in chagas patients?

NCT ID NCT04239144

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a procedure called bilateral sympathectomy, which cuts certain nerves to the heart, in 45 Chagas disease patients with implantable defibrillators (ICDs) who had frequent dangerous heart rhythms. Participants were randomly assigned to receive the nerve-cutting procedure, standard medication, or catheter ablation. The goal was to see if the nerve procedure could reduce the number of heart rhythm episodes and improve quality of life.

What this could mean

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

Active substance
bilateral sympathectomy (nerve-cutting procedure via video-assisted thoracoscopy)
What this could lead to
If it works, this could offer a new treatment option for controlling life-threatening heart rhythms in Chagas patients who don't respond to standard therapies.
What could go wrong
This is a small pilot study with only 45 participants, so results may not apply broadly. The procedure carries surgical risks, and it's unclear if it will outperform existing treatments.

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

45 people

The number who actually took part.

Started

Nov 2018

Finished

Dec 2025

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 years and older

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: * Patients with Chagas Disease Cardiomyopathy having an ICD * At least four appropriate ICD therapies in the past six months, documented by device interrogation or medical records; * Use of amiodarone and beta blockers in an optimized fashion; * Life expectancy of more than one year * Conditions for following the plan of clinical follow-up of the study. Exclusion criteria: * Presence of an absolute contraindication to receive any of the possible treatments of the study; * Pregnant Woman; * Less than 18 years-old; * Renal insufficiency with creatinine \>2.5 mg/dL (221 umol/L); * Mobile thrombus in the left ventricle; * Left Ventricle Ejection fraction \< 10%; * Unstable angina; * Severe aortic stenosis * Primary severe mitral insufficiency; * New York Heart Association (NYHA) functional class IV; * Previous cardiac surgery or scheduled.

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease Chagas cardiomyopathy Chagas disease ventricular tachycardia

As listed by the trial registrant

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

Chagas cardiomyopathy Ventricular arrythmia

Contacts and locations

Locations

  • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-900, Brazil

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