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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)

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NCT06372457

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
331actual
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-12-01actualWhen the study began enrolling
Primary completion2025-09-29actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-06-30estimatedThe whole study's end, after follow-up
First posted2024-04-18actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-04actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Hypertrophic Cardiomyopathy (HCM)

Interventions

  • Drug: Approved Hypertrophic Cardiomyopathy drug treatments
  • Drug: Mavacamten

Primary outcomes

what the primary-completion date above is the date OF
Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline, index date
Participant age at mavacamten treatment initiation
measured Index date
Participant sex
measured Baseline
Participant race/ethnicity
measured Baseline
Participant insurance coverage
measured Baseline
Participant employment status
measured Baseline
Participant educational level
measured Baseline
Date of Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline or index date
Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline or index date
Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis
measured Baseline or index date
Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline or index date, and up to 33 months
Participant New York Heart Association (NYHA) class
measured Baseline or index date, and up to 33 months
Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline
Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
measured Baseline
Participant height
measured Baseline
Participant weight
measured Baseline
Participant blood pressure
measured Baseline
Participant heart rate
measured Baseline
Participant Hypertrophic Cardiomyopathy (HCM) symptoms
measured Baseline or index date, and up to 33 months
European participant CYP2C19 genotype
measured Baseline or index date, and up to 33 months
Participant family history of Hypertrophic Cardiomyopathy (HCM)
measured Baseline or index date
Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)
measured Baseline or index date
Participant family history of sudden cardiac death (SCD)
measured Baseline or index date
Participant smoking status
measured Baseline or index date
Participant alcohol use
measured Baseline or index date
Participant recreational drug use
measured Baseline or index date
Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)
measured Baseline or index date, and up to 33 months
Participant cardiovascular (CV) and CV-related comorbidities
measured Baseline and index date
Participant non-cardiovascular (CV)-related comorbidities
measured Baseline or index date
Participant electrocardiogram (ECG) rhythm results
measured Baseline or index date
Participant cardiac magnetic resonance imaging (MRI) results
measured Baseline or index date
Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results
measured Baseline or index date
Participant cardiac troponin results
measured Baseline or index date
Participant cardiopulmonary exercise test (CPET) results
measured Baseline or index date
Participant cardiac monitoring results
measured Baseline or index date
Participant exercise test results
measured Baseline or index date
Participant blood creatine levels
measured Baseline or index date
Participant cardiovascular (CV) events
measured Baseline
Type of procedures received by participants
measured Baseline or index date, and up to 33 months
Cardiovascular treatments prescribed to participants
measured Baseline, and up to 33 months
Date of mavacamten prescription
measured Baseline
Date of mavacamten treatment initiation
measured Index date
Date of mavacamten dosage change
measured Up to 33 months
Reason for mavacamten dosage change
measured Up to 33 months
Occurrence of mavacamten stable dose (a period of 6-months with the same dose)
measured Up to 33 months
Dates of follow-up after mavacamten treatment initiation
measured Up to 33 months
Date of mavacamten treatment interuption or discontinuation
measured Up to 33 months
Reason for mavacamten treatment interuption or discontinuation
measured Up to 33 months
Supportive care provided to participants
measured Up to 33 months
Heath care resource utilization (HCRU)
measured Up to 33 months
Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation
measured Up to 33 months

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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