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NCT Number: NCT06372457

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertrophic Cardiomyopathy (HCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IQVIA

Durham, North Carolina, 27703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Approved Hypertrophic Cardiomyopathy drug treatments

Drug

As per product label

Mavacamten

Drug

As per product label

Primary outcomes

  1. Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline, index date

  2. Participant age at mavacamten treatment initiation

    Time frame: Index date

  3. Participant sex

    Time frame: Baseline

  4. Participant race/ethnicity

    Time frame: Baseline

  5. Participant insurance coverage

    Time frame: Baseline

  6. Participant employment status

    Time frame: Baseline

  7. Participant educational level

    Time frame: Baseline

  8. Date of Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline or index date

  9. Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline or index date

  10. Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis

    Time frame: Baseline or index date

  11. Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline or index date, and up to 33 months

  12. Participant New York Heart Association (NYHA) class

    Time frame: Baseline or index date, and up to 33 months

  13. Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline

  14. Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline

  15. Participant height

    Time frame: Baseline

  16. Participant weight

    Time frame: Baseline

  17. Participant blood pressure

    Time frame: Baseline

  18. Participant heart rate

    Time frame: Baseline

  19. Participant Hypertrophic Cardiomyopathy (HCM) symptoms

    Time frame: Baseline or index date, and up to 33 months

  20. European participant CYP2C19 genotype

    Time frame: Baseline or index date, and up to 33 months

  21. Participant family history of Hypertrophic Cardiomyopathy (HCM)

    Time frame: Baseline or index date

  22. Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)

    Time frame: Baseline or index date

  23. Participant family history of sudden cardiac death (SCD)

    Time frame: Baseline or index date

  24. Participant smoking status

    Time frame: Baseline or index date

  25. Participant alcohol use

    Time frame: Baseline or index date

  26. Participant recreational drug use

    Time frame: Baseline or index date

  27. Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)

    Time frame: Baseline or index date, and up to 33 months

  28. Participant cardiovascular (CV) and CV-related comorbidities

    Time frame: Baseline and index date

    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)

  29. Participant non-cardiovascular (CV)-related comorbidities

    Time frame: Baseline or index date

    Including:

    • Anxiety/panic attacks
    • Asthma
    • COPD
    • Depression
    • Diabetes
    • Liver diseases

  30. Participant electrocardiogram (ECG) rhythm results

    Time frame: Baseline or index date

  31. Participant cardiac magnetic resonance imaging (MRI) results

    Time frame: Baseline or index date

  32. Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results

    Time frame: Baseline or index date

  33. Participant cardiac troponin results

    Time frame: Baseline or index date

  34. Participant cardiopulmonary exercise test (CPET) results

    Time frame: Baseline or index date

  35. Participant cardiac monitoring results

    Time frame: Baseline or index date

  36. Participant exercise test results

    Time frame: Baseline or index date

  37. Participant blood creatine levels

    Time frame: Baseline or index date

  38. Participant cardiovascular (CV) events

    Time frame: Baseline

    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

  39. Type of procedures received by participants

    Time frame: Baseline or index date, and up to 33 months

    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)

  40. Cardiovascular treatments prescribed to participants

    Time frame: Baseline, and up to 33 months

  41. Date of mavacamten prescription

    Time frame: Baseline

  42. Date of mavacamten treatment initiation

    Time frame: Index date

  43. Date of mavacamten dosage change

    Time frame: Up to 33 months

  44. Reason for mavacamten dosage change

    Time frame: Up to 33 months

  45. Occurrence of mavacamten stable dose (a period of 6-months with the same dose)

    Time frame: Up to 33 months

  46. Dates of follow-up after mavacamten treatment initiation

    Time frame: Up to 33 months

  47. Date of mavacamten treatment interuption or discontinuation

    Time frame: Up to 33 months

  48. Reason for mavacamten treatment interuption or discontinuation

    Time frame: Up to 33 months

  49. Supportive care provided to participants

    Time frame: Up to 33 months

  50. Heath care resource utilization (HCRU)

    Time frame: Up to 33 months

  51. Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation

    Time frame: Up to 33 months

Secondary outcomes

  1. Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms

    Time frame: Baseline and index date

  2. Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)

    Time frame: Baseline, index date, and up to 33 months

  3. Participant family history of sudden cardiac death (SCD)

    Time frame: Baseline, index date, and up to 33 months

  4. Cardiovascular (CV) and CV-related comorbidities

    Time frame: Baseline

    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)

  5. Non-cardiovascular (non-CV) comorbidities

    Time frame: Baseline

    Including:

    • Anxiety/panic attacks
    • Asthma
    • COPD
    • Depression
    • Diabetes
    • Liver disease

  6. Participant electrocardiogram (ECG) rhythm results

    Time frame: Baseline

  7. Participant echocardiogram (ECHO) results

    Time frame: Baseline and index date

  8. Participant cardiac MRI results

    Time frame: Baseline

  9. Participant NT-proBNP results

    Time frame: Baseline

  10. Participant cardiac tropin results

    Time frame: Baseline

  11. Participant cardiopulmonary exercise test (CPET) results

    Time frame: Baseline

  12. Participant cardiac monitoring results

    Time frame: Baseline

  13. Participant exercise test results

    Time frame: Baseline

  14. Hypertrophic Cardiomyopathy (HCM) subtype

    Time frame: Baseline, index date, and up to 33 months

  15. Participant symptoms at Hypertrophic Cardiomyopathy (HCM)

    Time frame: Baseline, index date, and up to 33 months

  16. Participant New York Heart Association (NYHA) class

    Time frame: Baseline, index date, and up to 33 months

  17. Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline

  18. Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: COLLIGO-HCM

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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