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

NCT06372457 | Active Not Recruiting

• 1 other identifier: CV027-1107
• Study Type: observational
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes

Outcome Measures

Primary Outcomes (51)

• Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis

  Baseline, index date

• Participant age at mavacamten treatment initiation

  Index date

• Participant sex

  Baseline

• Participant race/ethnicity

  Baseline

• Participant insurance coverage

  Baseline

• Participant employment status

  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 height

  Baseline

• Participant weight

  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 Outcomes (18)

• 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

  Baseline

• Non-cardiovascular (non-CV) comorbidities

  Baseline

Study Arms (2)

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

Participants treated with mavacamten.

Drug: Mavacamten

Interventions

Approved Hypertrophic Cardiomyopathy drug treatments DRUG

As per product label

Participants with Hypertrophic Cardiomyopathy (HCM)

Mavacamten DRUG

As per product label

Participants treated with mavacamten.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

IQVIA

Durham, North Carolina, 27703, United States

Location

Related Publications (1)

• 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.

  PMID: 41212168 DERIVED

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: December 1, 2023
• Primary Completion: September 29, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)