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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertrophic Cardiomyopathy (HCM)
• Intervention / Treatment: Drug: Approved Hypertrophic Cardiomyopathy drug treatments; Drug: Mavacamten

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.

• Study Type: Observational
• Enrollment (Actual): 331

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • IQVIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients who have been diagnosed with Hypertrophic Cardiomyopathy (HCM).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Hypertrophic Cardiomyopathy (HCM); Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy	Drug: Approved Hypertrophic Cardiomyopathy drug treatments; As per product label
Participants treated with mavacamten.	Drug: Mavacamten; As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant sex		Baseline
Participant employment status		Baseline
Participant height		Baseline
Participant weight		Baseline
Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline, index date
Participant age at mavacamten treatment initiation		Index date
Participant race/ethnicity		Baseline
Participant insurance coverage		Baseline
Participant educational level		Baseline
Date of Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date
Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date
Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis		Baseline or index date
Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date, and up to 33 months
Participant New York Heart Association (NYHA) class		Baseline or index date, and up to 33 months
Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Participant blood pressure		Baseline
Participant heart rate		Baseline
Participant Hypertrophic Cardiomyopathy (HCM) symptoms		Baseline or index date, and up to 33 months
European participant CYP2C19 genotype		Baseline or index date, and up to 33 months
Participant family history of Hypertrophic Cardiomyopathy (HCM)		Baseline or index date
Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)		Baseline or index date
Participant family history of sudden cardiac death (SCD)		Baseline or index date
Participant smoking status		Baseline or index date
Participant alcohol use		Baseline or index date
Participant recreational drug use		Baseline or index date
Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)		Baseline or index date, and up to 33 months
Participant cardiovascular (CV) and CV-related comorbidities	Comorbidities include: Aortic stenosis; Cardiomyopathies, other (dilated, restrictive, arrhythmogenic right ventricular dysplasia, takotsubo cardiomyopathy); Chronic kidney disease; Coronary heart disease; Deep venous thrombosis (DVT); Heart failure; Hyperlipidemia; Hypertension; Hypertensive renal disease; Mitral valve prolapse; Peripheral vascular disease; Pulmonary hypertension; Phenocopy disorders (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis)	Baseline and index date
Participant non-cardiovascular (CV)-related comorbidities	Including: Anxiety/panic attacks; Asthma; COPD; Depression; Diabetes; Liver diseases	Baseline or index date
Participant electrocardiogram (ECG) rhythm results		Baseline or index date
Participant cardiac magnetic resonance imaging (MRI) results		Baseline or index date
Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results		Baseline or index date
Participant cardiac troponin results		Baseline or index date
Participant cardiopulmonary exercise test (CPET) results		Baseline or index date
Participant cardiac monitoring results		Baseline or index date
Participant exercise test results		Baseline or index date
Participant blood creatine levels		Baseline or index date
Participant cardiovascular (CV) events	Cardiovascular events include: Atrial fibrillation; Atrial flutter; Myocardial infarction (MI); Stroke; Transient ischemic attack (TIA); Cardiac arrest; Sudden cardiac death (SCD); Arrhythmia; Heart failure exacerbation; Incident heart failure; Ventricular fibrillation; Syncope	Baseline
Type of procedures received by participants	Procedures include: Septal reduction therapy (SRT); Implantable cardioverter defibrillator (ICD), including CRT-D; Pacemaker; Cardiac resynchronization therapy (CRT); Atrial fibrillation ablation; Cardioversion; Heart transplant/use of ventricular assist device; Heart failure monitoring (e.g., CardioMEMS); Percutaneous cutaneous intervention (PCI)	Baseline or index date, and up to 33 months
Cardiovascular treatments prescribed to participants		Baseline, and up to 33 months
Date of mavacamten prescription		Baseline
Date of mavacamten treatment initiation		Index date
Date of mavacamten dosage change		Up to 33 months
Reason for mavacamten dosage change		Up to 33 months
Occurrence of mavacamten stable dose (a period of 6-months with the same dose)		Up to 33 months
Dates of follow-up after mavacamten treatment initiation		Up to 33 months
Date of mavacamten treatment interuption or discontinuation		Up to 33 months
Reason for mavacamten treatment interuption or discontinuation		Up to 33 months
Supportive care provided to participants		Up to 33 months
Heath care resource utilization (HCRU)		Up to 33 months
Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation		Up to 33 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms		Baseline and index date
Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)		Baseline, index date, and up to 33 months
Participant family history of sudden cardiac death (SCD)		Baseline, index date, and up to 33 months
Cardiovascular (CV) and CV-related comorbidities	Including: Aortic stenosis; Cardiomyopathies; Chronic kidney disease; Coronary heart disease; Heart failure; Hyperlipidemia; Hypertension (primary); Hypertensive renal disease; Mitral valve prolapse; Peripheral vascular disease; Pulmonary hypertension; Phenocopy disorders (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis)	Baseline
Non-cardiovascular (non-CV) comorbidities	Including: Anxiety/panic attacks; Asthma; COPD; Depression; Diabetes; Liver disease	Baseline
Participant electrocardiogram (ECG) rhythm results		Baseline
Participant echocardiogram (ECHO) results		Baseline and index date
Participant cardiac MRI results		Baseline
Participant NT-proBNP results		Baseline
Participant cardiac tropin results		Baseline
Participant cardiopulmonary exercise test (CPET) results		Baseline
Participant cardiac monitoring results		Baseline
Participant exercise test results		Baseline
Hypertrophic Cardiomyopathy (HCM) subtype		Baseline, index date, and up to 33 months
Participant symptoms at Hypertrophic Cardiomyopathy (HCM)		Baseline, index date, and up to 33 months
Participant New York Heart Association (NYHA) class		Baseline, index date, and up to 33 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Bilen O, Adler A, Bastiaenen R, MacNamara JP, Paratz E, Maor E, Arad M, Gold M, Patel N, Pruett C, Burford E, Arora G, Maksabedian Hernandez EJ, Han X, Schuler P, Sandler B, Li L, Tian D, Arora P; COLLIGO-HCM investigators. Mavacamten Monotherapy in Real-World Patients With Obstructive Hypertrophic Cardiomyopathy: Evidence From COLLIGO-HCM. Circ Genom Precis Med. 2026 Feb;19(1):e005502. doi: 10.1161/CIRCGEN.125.005502. Epub 2025 Nov 10.

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 29, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic; MYK-461
• Other Study ID Numbers: CV027-1107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No