Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05939700

Mavacamten Pregnancy Surveillance Program

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breastfeeding Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Behavior Breast Feeding Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Feeding Behavior Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Pregnancy Related

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Mavacamten Pregnancy Surveillance Program, PPD Inc

Wilmington, North Carolina, 28401-3331, United States

Location status: Recruiting

Location contact

The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc

CONTACT

[email protected]

877-390-2852

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mavacamten

Drug

Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding

Primary outcomes

  1. Pregnancy outcomes

    Time frame: Up to 10 months

    (1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications

  2. Fetal/neonatal/infant outcomes

    Time frame: Up to 12 months post pregnancy outcome

    Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2023
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.