Mavacamten Pregnancy Surveillance Program

Recruiting now

Conditions studied: Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related

In brief

The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.

Key facts

Study ID

NCT05939700

Run by

Bristol-Myers Squibb

People needed

20

Starts

2023-11-09

Expected to finish

2027-04-30

Last updated by the study team

2025-11-06

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

• The Mavacamten Pregnancy Surveillance Program, PPD Inc — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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