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Recruiting NCT05939700

Mavacamten Pregnancy Surveillance Program

— Observational Breastfeeding Hypertrophic Cardiomyopathy Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mavacamten.
Who it may be relevant to
Registry conditions: Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related. Basic parameters: from 15 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Pregnancy outcomes [Time frame: Up to 10 months]
  • Fetal/neonatal/infant outcomes [Time frame: Up to 12 months post pregnancy outcome]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Mavacamten Pregnancy Surveillance Program, PPD Inc — Wilmington

Identifiers

NCT: NCT05939700 · CV027-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗