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Heart scar on MRI may decide who gets a lifesaving shock device

NCT ID NCT07415642

Disease control Sponsor: University Medical Center Groningen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether an implantable defibrillator (ICD) can reduce the risk of sudden cardiac death in people with non-ischemic dilated cardiomyopathy, a type of heart muscle disease not caused by blocked arteries. Researchers will use MRI scans to find heart scarring (fibrosis) and then randomly assign those with scarring to either get an ICD or continue standard medication. The goal is to see if the ICD improves survival and helps doctors better predict who is at highest risk.

What this could mean

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

Active substance
Implantable Cardioverter-Defibrillator (ICD)
What this could lead to
If successful, this could show that an ICD saves lives in certain heart muscle disease patients and help doctors better identify who needs one.
What could go wrong
The trial hasn't started yet, and it's possible that ICDs may not reduce overall death risk or that complications from the device outweigh benefits.

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 720 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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 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: * Non-ischemic cardiomyopathy * Left ventricular late gadolinium enhancement on MRI, but not hinge-point fibrosis * Left ventricular ejection fraction \<35% on any modality * Functional class NYHA I-III * At least 3 months optimal medical treatment for heart failure Exclusion Criteria: * Indication for cardiac resynchronization therapy * Functional class NYHA IV * Typical ischemic scar tissue on CMR * Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease * high-risk mutations causing DCM * Patient on waiting list for heart transplantation * Left ventricular assist device present * Severe valve disease * Secondary prevention indication for ICD * Untreated cardiac ischemia * High competing risk of death (\>35% in 1 year according to HFmetascore) * Active chemotherapy for cancer * Severe renal failure with dialysis expected within 3 years

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac dilated cardiomyopathy heart failure sudden arrhythmia death syndrome sudden cardiac arrest

As listed by the trial registrant

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

Sudden cardiac death

How to take part

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

  1. The places running it

    2 sites. 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. 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

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.