NCT06549608

Brief Summary

This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program in Canada.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
685

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

16 days

First QC Date

August 8, 2024

Last Update Submit

February 21, 2025

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (2)

  • Participant demographics

    Baseline

  • Participant clinical characteristics

    Baseline

Secondary Outcomes (3)

  • Dose regimen of mavacamten treatment

    Every 3-months up to 14 months

  • Titration patterns of mavacamten treatment

    Up to 14 months

  • Mavacamten treatment duration

    Up to 14 months

Study Arms (1)

Adults participants treated with mavacamten

Participants with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care.

Drug: Mavacamten

Interventions

MavacamtenDRUG

As per product label

Adults participants treated with mavacamten

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants in Canada diagnosed with hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment as part of the BMS-sponsored CAMZYOS Patient Support Program

You may qualify if:

  • Participants ≥18 years of age.
  • Participants who have initiated mavacamten as part of routine clinical care, through the BMS-sponsored CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
  • Participants who consented to the use of their de-identified data, generated from information collected in the course of the program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Related Links

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart 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

August 8, 2024

First Posted

August 12, 2024

Study Start

April 20, 2024

Primary Completion

May 6, 2024

Study Completion

April 18, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)