Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

NCT ID: NCT06551129

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-10

Study Completion Date

2027-06-30

Brief Summary

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This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

Detailed Description

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Conditions

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Obstructive Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mavacamten

Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten

Mavacamten

Intervention Type DRUG

As prescribed by treating physician

Interventions

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Mavacamten

As prescribed by treating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants ≥18 years of age.
* Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
* Provided informed consent to participate in the study

Exclusion Criteria

* Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
* Treated for \>7 days with mavacamten by the day of completing the baseline survey
* Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
* Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
* Had stroke or transient ischemic attack within the six-month period prior to the screening
* Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
* Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
* Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
* Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Analysis Group Inc.

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Facility Contacts

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Min Yang, Site 0001

Role: primary

Related Links

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Other Identifiers

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CV027-1002

Identifier Type: -

Identifier Source: org_study_id

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