Mavacamten Pregnancy Surveillance Program

NCT05939700 | Recruiting FDA Drug

• 1 other identifier: CV027-014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Hypertrophic Cardiomyopathy; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Pregnancy outcomes

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

  Up to 10 months

• Fetal/neonatal/infant outcomes

  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

  Up to 12 months post pregnancy outcome

Study Arms (1)

Cohort 1

Pregnant or breastfeeding women exposed to mavacamten

Drug: Mavacamten

Interventions

Mavacamten DRUG

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

Cohort 1

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

The Mavacamten Pregnancy Surveillance Program, PPD Inc

Wilmington, North Carolina, 28401-3331, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Breast Feeding; Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)