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COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Active, not recruiting

Conditions

Hypertrophic Cardiomyopathy (HCM)

Treatments

Drug: Approved Hypertrophic Cardiomyopathy drug treatments
Drug: Mavacamten

Study type

Observational

Funder types

Industry

Identifiers

NCT06372457
CV027-1107

Details and patient eligibility

About

COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.

Full description

The mavaCamten ObservationaL evIdence Global cOnsortium in hypertrophic cardiomyopathy (COLLIGO-HCM) is a global observational research initiative aiming to describe the real-world outcomes of treatments for obstructive hypertrophic cardiomyopathy (HCM), including mavacamten.

This retrospective study uses data from existing medical records and electronic registries from HCM centers around the world.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Source Cohort

    • Have at least one recorded encounter with a Hypertrophic Cardiomyopathy (HCM) diagnosis during or after 2018 (the first is defined as the index) and aged ≥18 years on the index date.

    • Disease-specific patient history documented in the medical record.

  • HCM Sub-Cohort

    • Participants in the source cohort with a known HCM diagnosis
  • Mavacamten Sub-Cohort - Participants who have their first mavacamten prescription after the index date

Exclusion criteria

• HCM Sub-Cohort

  • HCM phenocopy (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis) observed after the first observed HCM-associated encounter in the medical record.

Trial design

500 participants in 2 patient groups

Participants with Hypertrophic Cardiomyopathy (HCM)
Description:
Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy
Treatment:
Drug: Approved Hypertrophic Cardiomyopathy drug treatments
Participants treated with mavacamten.
Treatment:
Drug: Mavacamten

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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