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Heart scarring over time: new study aims to predict sudden death risk in HCM patients

NCT ID NCT07054073

Knowledge-focused Sponsor: Christopher Kramer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows up on people with hypertrophic cardiomyopathy (HCM), a genetic condition that thickens the heart muscle. Researchers want to see how scarring in the heart (called late gadolinium enhancement, or LGE) changes over at least 7 years and whether it predicts serious problems like sudden cardiac arrest or heart failure. About 314 participants from an earlier study will get repeat MRI scans to track these changes.

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.

Participants

About 314 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

Jul 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.

Who is studied

Participants from the HCMR original cohort who also meet this study's eligibility criteria.

Ages

18 to 65 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: Patients in the original HCMR cohort with: 1. Obstructive HCM * Males and females between 18 and 65 years of age * BMI \< 35 kg/m2 * LVOT-G at entry as follows: Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg • NYHA Class II or III or 2. Non-obstructive HCM * Same criteria as above except resting LVOT-G is \<30mmHg and post-Valsalva gradient \<50mm Hg * BMI \<40kg/m2 * Elevated NT-proBNP \> 300 pg/mL at the time of enrollment * LVEF ≥55% Exclusion Criteria: * Paroxysmal atrial fibrillation or flutter documented prior to entry. * Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for \>6 months.) * History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry. * Pregnancy due to potential risk of gadolinium to the fetus * Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

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

Hypertrophic cardiomyopathy (HCM)

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • Brigham & Women's Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • London Chest Hospital

    NOT_YET_RECRUITING

    London, E2 9JX, United Kingdom

  • Northwestern

    NOT_YET_RECRUITING

    Evanston, Illinois, 60208, United States

  • Tufts Medical Center

    NOT_YET_RECRUITING

    Medford, Massachusetts, 02155, United States

  • University Hospitals Birmingham NHS Foundation Trust

    NOT_YET_RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

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