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New study tracks rare genetic heart condition to guide future treatments

NCT ID NCT05981092

Knowledge-focused Sponsor: Alexion Pharmaceuticals, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows about 35 people with dilated cardiomyopathy caused by a BAG3 gene mutation, a condition that weakens the heart muscle. Over three years, researchers will monitor heart function, symptoms, and quality of life using tests like imaging and blood work. The goal is to understand how the disease progresses naturally, which could help design better treatments in the future.

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 study could help researchers better understand BAG3-related heart disease and design future treatments.
What could go wrong
This is an observational study with only 35 participants, so findings may not apply to everyone. It does not test any new treatment.

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

35 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

primary care clinic and referrals from primary care clinic to investigational sites

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: * Documented BAG3 mutation that causes or is likely to cause dilated cardiomyopathy * Heart failure Stage B-D, New York Heart Association (NYHA) Class I-IV * Left Ventricular Ejection Fraction ≤50% (i.e., Reduced Heart Function) Exclusion Criteria: * Acute decompensated heart failure within 1 month prior to enrollment.(such as hospitalization) * Any of the following within 3 months prior to screening: myocardial infarction (MI), cardiac surgical procedures (other than for pacemaker/ICD/CRT-defibrillator \[CRT-D\] implantation), acute coronary syndrome, or hospitalization for cardiac arrhythmia. * History of heart transplantation * eGFR \<30 mL/min/1.73 m2 (significantly impaired kidney function) * Noncardiac condition that limits lifespan to \<1 year. * Presence of other form(s) of cardiomyopathy contributing to heart failure * Previous administration with an investigational drug within 30 days (or as determined by the local requirement). * No more than 3 first-degree members of the same family who are already participating in the study

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Conditions

The condition(s) this trial relates to.

cardiomyopathy dilated cardiomyopathy dilated cardiomyopathy 1HH heart disorder

As listed by the trial registrant

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

BCL-2 anathogene-3 (BAG3) dilated cardiomyopathy (DCM) Cardiomyopathy, dilated

Contacts and locations

Locations

  • Research Site

    Palo Alto, California, 94305, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Boston, Massachusetts, 02115, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    The Bronx, New York, 10467, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Amsterdam, Amsterdam, 1105 AZ, Netherlands

  • Research Site

    Maastricht, Maastricht, 6229 HX, Netherlands

  • Research Site

    Warsaw, Warszawa, 04-628, Poland

  • Research Site

    A Coruña, A Coruna, 15006, Spain

  • Research Site

    Madrid, Madrid, 28041, Spain

  • Research Site

    Majadahonda, Madrid, 28222, Spain

  • Research Site

    El Palmar, Murcia, 30120, Spain

  • Research Site

    Harefield, London, UB9 6JH, United Kingdom

  • Research Site

    London, London, EC1A 7BE, United Kingdom

More trials for these conditions

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