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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) | Clinical Trials | Clareo Health

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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)

mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)

NCT06372457•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

IQVIA

Durham, North Carolina, United States

Key Dates

Start Date

December 1, 2023

Primary Completion Date

March 1, 2025

Completion Date

June 15, 2025

Last Updated

April 18, 2024

Enrollment

500

ESTIMATED participants

Conditions

Hypertrophic Cardiomyopathy (HCM)

Interventions

Approved Hypertrophic Cardiomyopathy drug treatments

DRUG

Mavacamten

DRUG

HCMR Re-Imaging Study

NCT07054073

Hypertrophic Cardiomyopathy (HCM)

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RECRUITING

Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)

NCT07344480

Hypertrophic Cardiomyopathy (HCM)Heart Failure+1 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

HCMR Re-Imaging Study

Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)

Multimodal Analysis of Endomyocardial Biopsies

The Application of T1 Mapping in Real-World

AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

One-stop Evaluation of Hypertrophic Cardiomyopathy in Cardiac Magnetic Resonance