Cardiomyopathy Trial, Recruiting NCT05489705 Sponsor: Bristol-Myers Squibb Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT05489705
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years of age or older at the time you agree to take part.
  • You must be willing and able to sign a consent form before the study begins (or have a legal representative do so on your behalf if you are unable to).

If applying for the US part of the study:

  • You have been diagnosed with obstructive hypertrophic cardiomyopathy (a condition where the heart muscle is thickened and blocks blood flow) according to recognised medical guidelines.
  • An ultrasound of your heart (echocardiogram) taken within the last 6 months must show your heart is pumping at 55% or more of its normal capacity.
  • You have symptoms of this condition that range from mild (noticeable during activity) to severe (present even at rest).
  • You are currently taking certain heart medications (such as beta blockers, certain calcium channel blockers, disopyramide, and/or mavacamten) as part of your regular care, or you are not taking any medication because you could not tolerate or did not respond to previous treatments.

If applying for the European part of the study:

  • You have been diagnosed with obstructive hypertrophic cardiomyopathy according to recognised medical guidelines.
  • An echocardiogram must show your heart is pumping at 55% or more of its normal capacity.
  • You have had noticeable symptoms (ranging from mild to moderate) either currently or within the last 6 months.
  • You are currently taking certain heart medications as part of your regular care, starting mavacamten at the time of enrolment, or not taking any medication due to intolerance or previous treatment failure.

Who may not be able to join:

  • You have a condition that mimics hypertrophic cardiomyopathy but has a different cause, such as Fabry disease, amyloidosis, or thickening of the heart muscle caused by high blood pressure.
  • You have a permanent physical blockage in the outflow of your heart, such as aortic valve narrowing or a replaced aortic valve.
  • You have had an invasive procedure to treat this condition (such as surgery on the heart muscle or an alcohol-based procedure to reduce the blockage) within the last 6 months (though you may still be eligible if the procedure was more than 6 months ago and was unsuccessful — confirm with trial site).
  • You have never been treated with any standard medications for this condition (such as beta blockers, certain calcium channel blockers, or disopyramide).

US part of the study — you may also not be able to join if:

  • You are currently taking part in another clinical trial testing an experimental treatment for this heart condition (other than mavacamten).
  • You have previously or are currently enrolled in a long-term safety study of mavacamten (specific named studies listed in the official criteria).

European part of the study — you may also not be able to join if:

  • You are currently taking any experimental treatment or any heart muscle-targeting drug for this condition at the time of enrolment.
  • You are currently or have previously been enrolled in other hypertrophic cardiomyopathy registry studies (such as TORCH, REMY, or EU-PASS).
  • You have previously or are currently enrolled in any study involving mavacamten (specific named studies listed in the official criteria).
  • You have previously been treated with mavacamten at any point.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Phone: 855-907-3286

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
16 August 2022
Est. completion
17 August 2029

Where this trial is recruiting

🇦🇹 Austria 🇫🇷 France 🇩🇪 Germany Puerto Rico 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment; Change in resting left ventricular outflow tract (LVOT) gradient from baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov