COLLIGO-HCM
Research type
Research Study
Full title
mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)
IRAS ID
336452
Contact name
Ervant Maksabedian Hernandez
Contact email
Sponsor organisation
Bristol-Myers Squibb,
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
The purpose of the study is understanding treatment choices and real-world effectiveness for hypertrophic cardiomyopathy (HCM), including the influence of path to diagnosis, disease progression, and the availability of a new treatment for obstructive HCM i.e., mavacamten. The study is expected to generate important insights that could inform future treatment options for HCM.
The study will only use health care data recorded as part of routine clinical care. Pseudonymised, patient-level data will be retrospectively extracted from the EMR by patient’s direct care team at participating sites. The participating site in the UK is Guys and St Thomas Hospital.
The main study cohort will be the overall HCM cohort, defined as adults with HCM represented in each site’s medical record database or local registry with at least one visit from 2018 until the date of data extraction. Both previously diagnosed and newly diagnosed patients will be included. The subset of patients treated with mavacamten in the overall HCM cohort will constitute the mavacamten sub cohort. The follow-up period for both cohorts will end at death, loss to follow-up (for registries), exit from the database (for routinely collected data), participation in a randomised controlled trial that includes a drug similar to mavacamten , or the time of data extraction, whichever occurs first.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0100
Date of REC Opinion
1 May 2024
REC opinion
Favourable Opinion