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New study uses tiny heart monitor to uncover hidden rhythm risks in fabry disease

NCT ID NCT04440254

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 40 men with Fabry disease for three years using a small device implanted under the skin that continuously records heart rhythms. The goal is to see how often dangerous heart rhythm problems occur and how they relate to other changes in the heart and body. No new treatment is being tested; the study aims to better understand the disease.

What this could mean

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

What this could lead to
If successful, this could help doctors better predict and manage heart rhythm problems in people with Fabry disease.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not apply to all patients.

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 40 people

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

Started

May 2021

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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

Male participants only

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: * Male patient * Age greater than or equal to 18 years on the day of inclusion * Presence of a morbid mutation for MF * Signature of the informed consent form * Absence of significant valve disease, verified on medical file (absence stenosis or regurgitation \<2+ in color Doppler on a scale 1 to 4+ by extension of the jet) * No history of known or documented myocardial infarction nor CAD * No pacemaker or ICD * no history of AF, NSVT, high-degree AV block * Correct echogenicity * No treatment by corticosteroid or immunosuppressive drugs * creatinine clearance \>/= 30 Ml/mn * LVEF ≥ 50% by ultrasound and / or MRI * No contraindication to MRI (or claustrophobia) and gadolinium injection * Affiliation to the French social security insurance

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Conditions

The condition(s) this trial relates to.

Fabry disease

As listed by the trial registrant

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

Fabry disease

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

  • 20 Rue Leblanc, HEGP/PARCC, 75015 Paris

    RECRUITING

    Paris, Paris, 75015, France

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