A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada

February 21, 2025 updated by: Bristol-Myers Squibb

Patient Characteristics and Treatment Duration of Mavacamten Obstructive HCM Patient Support Program in Canada: A Retrospective Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant demographics
Time Frame: Baseline
Baseline
Participant clinical characteristics
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose regimen of mavacamten treatment
Time Frame: Every 3-months up to 14 months
Every 3-months up to 14 months
Titration patterns of mavacamten treatment
Time Frame: Up to 14 months
Up to 14 months
Mavacamten treatment duration
Time Frame: Up to 14 months
Up to 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Actual)

May 6, 2024

Study Completion (Estimated)

April 18, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1187

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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