Monitoring the effects of mavacamten during pregnancy and breastfeeding
Mavacamten Pregnancy Surveillance Program
This study is testing how safe the heart medication mavacamten is for mothers and their babies during pregnancy and breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT05939700 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have taken mavacamten during pregnancy or breastfeeding and are at least 15 years old.
Not a fit: Patients who have not been exposed to mavacamten during pregnancy or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide critical safety information for mothers and infants exposed to mavacamten during pregnancy and breastfeeding.
How similar studies have performed: While this specific approach is observational and may not have been extensively tested, similar studies assessing medication safety during pregnancy have shown the importance of monitoring outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wilmington, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.