BMS

  • Research type

    Research Study

  • Full title

    Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World (DISCOVER-HCM): United States Prospective Registry Study

  • IRAS ID

    349402

  • Contact name

    Robert Cooper

  • Contact email

    Rob.Cooper@lhch.nhs.uk

  • Sponsor organisation

    Bristol Meyer Squibb

  • Duration of Study in the UK

    3 years, 0 months, 2 days

  • Research summary

    To evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) in the real-world setting. The registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients with symptomatic obstructive HCM who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment.
    Because this is an observational registry study, no medications or other treatments are provided to the participants.
    Participation in the study is expected to last eighteen (18) months, with 3 follow-up visits. Eligible will be all patients, willing and able to provide written informed consent form, diagnosis of obstructive HCM, Documented LVEF of ≥55% recorded by TTE, Documented symptoms consistent with NYHA functional class II–III at enrollment or within 6 months prior to enrollment, 18 years old or older.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    24/EM/0283

  • Date of REC Opinion

    24 Feb 2025

  • REC opinion

    Further Information Favourable Opinion