Monitoring the effects of mavacamten during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program aims to evaluate the safety of mavacamten exposure during pregnancy and breastfeeding by assessing maternal, fetal, and infant outcomes. Participants must have received at least one dose of mavacamten at any time from four months prior to conception through the outcome of the pregnancy or during breastfeeding. The study will gather data on the health effects for both mothers and infants to ensure safety and inform future use of the medication in these populations.

Why it matters

Who can join: the full rules

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

Where it's running

• The Mavacamten Pregnancy Surveillance Program, PPD Inc
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.