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Hypertrophic Cardiomyopathy (HCM)COLLIGO-HCMNCT06372457

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

An observational study of Hypertrophic Cardiomyopathy (HCM), run by Bristol-Myers Squibb at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertrophic Cardiomyopathy (HCM)
What is being tested?
Approved Hypertrophic Cardiomyopathy drug treatments and Mavacamten
How many people
331 participants
Where
1 siteUnited States
Study dates
1 Dec 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • IQVIA

    Durham, North Carolina, 27703

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Approved Hypertrophic Cardiomyopathy drug treatments, Mavacamten
Keywords
mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Approved Hypertrophic Cardiomyopathy drug treatmentsDrug

    As per product label

  • MavacamtenDrug

    As per product label

Study groups in NCT06372457
Study groupRoleWhat they receive
Participants with Hypertrophic Cardiomyopathy (HCM)Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy
Receives: Drug: Approved Hypertrophic Cardiomyopathy drug treatments
Participants treated with mavacamten.Not described
Receives: Drug: Mavacamten

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis

    Measured: Baseline, index date

  2. Participant age at mavacamten treatment initiation

    Measured: Index date

  3. Participant sex

    Measured: Baseline

  4. Participant race/ethnicity

    Measured: Baseline

  5. Participant insurance coverage

    Measured: Baseline

  6. Participant employment status

    Measured: Baseline

  7. Participant educational level

    Measured: Baseline

  8. Date of Hypertrophic Cardiomyopathy (HCM) diagnosis

    Measured: Baseline or index date

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

    Measured: Baseline or index date

  10. Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis

    Measured: Baseline or index date

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

    Measured: Baseline or index date, and up to 33 months

  12. Participant New York Heart Association (NYHA) class

    Measured: Baseline or index date, and up to 33 months

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

    Measured: Baseline

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

    Measured: Baseline

  15. Participant height

    Measured: Baseline

  16. Participant weight

    Measured: Baseline

  17. Participant blood pressure

    Measured: Baseline

  18. Participant heart rate

    Measured: Baseline

  19. Participant Hypertrophic Cardiomyopathy (HCM) symptoms

    Measured: Baseline or index date, and up to 33 months

  20. European participant CYP2C19 genotype

    Measured: Baseline or index date, and up to 33 months

  21. Participant family history of Hypertrophic Cardiomyopathy (HCM)

    Measured: Baseline or index date

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

    Measured: Baseline or index date

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

    Measured: Baseline or index date

  24. Participant smoking status

    Measured: Baseline or index date

  25. Participant alcohol use

    Measured: Baseline or index date

  26. Participant recreational drug use

    Measured: Baseline or index date

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

    Measured: Baseline or index date, and up to 33 months

  28. 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)

    Measured: Baseline and index date

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

    Including:

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

    Measured: Baseline or index date

  30. Participant electrocardiogram (ECG) rhythm results

    Measured: Baseline or index date

  31. Participant cardiac magnetic resonance imaging (MRI) results

    Measured: Baseline or index date

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

    Measured: Baseline or index date

  33. Participant cardiac troponin results

    Measured: Baseline or index date

  34. Participant cardiopulmonary exercise test (CPET) results

    Measured: Baseline or index date

  35. Participant cardiac monitoring results

    Measured: Baseline or index date

  36. Participant exercise test results

    Measured: Baseline or index date

  37. Participant blood creatine levels

    Measured: Baseline or index date

  38. 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

    Measured: Baseline

  39. 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)

    Measured: Baseline or index date, and up to 33 months

  40. Cardiovascular treatments prescribed to participants

    Measured: Baseline, and up to 33 months

  41. Date of mavacamten prescription

    Measured: Baseline

  42. Date of mavacamten treatment initiation

    Measured: Index date

  43. Date of mavacamten dosage change

    Measured: Up to 33 months

  44. Reason for mavacamten dosage change

    Measured: Up to 33 months

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

    Measured: Up to 33 months

  46. Dates of follow-up after mavacamten treatment initiation

    Measured: Up to 33 months

  47. Date of mavacamten treatment interuption or discontinuation

    Measured: Up to 33 months

  48. Reason for mavacamten treatment interuption or discontinuation

    Measured: Up to 33 months

  49. Supportive care provided to participants

    Measured: Up to 33 months

  50. Heath care resource utilization (HCRU)

    Measured: Up to 33 months

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

    Measured: Up to 33 months

Secondary outcomes (18)

  1. Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms

    Measured: Baseline and index date

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

    Measured: Baseline, index date, and up to 33 months

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

    Measured: Baseline, index date, and up to 33 months

  4. 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)

    Measured: Baseline

  5. Non-cardiovascular (non-CV) comorbidities

    Including:

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

    Measured: Baseline

  6. Participant electrocardiogram (ECG) rhythm results

    Measured: Baseline

  7. Participant echocardiogram (ECHO) results

    Measured: Baseline and index date

  8. Participant cardiac MRI results

    Measured: Baseline

  9. Participant NT-proBNP results

    Measured: Baseline

  10. Participant cardiac tropin results

    Measured: Baseline

  11. Participant cardiopulmonary exercise test (CPET) results

    Measured: Baseline

  12. Participant cardiac monitoring results

    Measured: Baseline

  13. Participant exercise test results

    Measured: Baseline

  14. Hypertrophic Cardiomyopathy (HCM) subtype

    Measured: Baseline, index date, and up to 33 months

  15. Participant symptoms at Hypertrophic Cardiomyopathy (HCM)

    Measured: Baseline, index date, and up to 33 months

  16. Participant New York Heart Association (NYHA) class

    Measured: Baseline, index date, and up to 33 months

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

    Measured: Baseline

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start1 Dec 2023
  3. Primary completion29 Sep 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372457
Sponsor's protocol ID
CV027-1107
Acronym
COLLIGO-HCM
Status last verified
Sep 2026
First submitted
15 Apr 2024
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41212168

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertrophic Cardiomyopathy (HCM), run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis (time frame: Baseline, index date). The study lists 51 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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