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New study tracks safety of heart drug mavacamten in pregnancy

NCT ID NCT05939700

Knowledge-focused Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study is looking at the safety of the heart medication mavacamten when taken during pregnancy or while breastfeeding. Researchers will follow about 20 people who have taken at least one dose of mavacamten during pregnancy or breastfeeding, tracking outcomes for both the mother and baby up to one year after birth. The goal is to better understand any risks or complications, not to test a new treatment.

What this could mean

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

Active substance
Mavacamten
What this could lead to
If this study succeeds, it could provide important safety information about using mavacamten during pregnancy and breastfeeding, helping doctors and patients make informed decisions.
What could go wrong
This is a small observational study with only 20 participants, so results may not apply to everyone. It is designed to gather data, not to test a new treatment, so no direct health benefits are expected for participants.

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 20 people

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

Started

Nov 2023

Expected to finish

Apr 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

Individuals 15 years of age or older who are exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding.

Ages

15 years and older

Sex

Female participants only

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: * Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first) * At least 15 years of age or older at the time of enrollment * Informed consent or institutional review board/ethics committee-approved waiver of informed consent Exclusion Criteria: \- None

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Conditions

The condition(s) this trial relates to.

Breast Feeding hypertrophic cardiomyopathy pregnancy disorder

As listed by the trial registrant

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

Breastfeeding Hypertrophic cardiomyopathy Pregnancy related

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • The Mavacamten Pregnancy Surveillance Program, PPD Inc

    RECRUITING

    Wilmington, North Carolina, 28401-3331, United States

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