Recruiting

Mavacamten Real-World Effectiveness and Safety in Obstructive Hypertrophic Cardiomyopathy

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Study Aim

This observational study aims to monitor and evaluate the safety and effectiveness of Mavacamten in individuals with obstructive hypertrophic cardiomyopathy, focusing on the actions taken after adverse events and their outcomes.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Aortic Valve Disease+5

+ Aortic Stenosis, Subvalvular

+ Aortic Valve Stenosis

Over 18 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2025
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Study ContactBMS Study Connect Contact Center www.BMSStudyConnect.comMore contacts
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 21, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a medication called mavacamten in patients with a heart condition known as obstructive hypertrophic cardiomyopathy (oHCM) in Japan. The goal is to understand how well the drug works in real-world settings for individuals with this specific condition. The study is important as it aims to provide insights into the drug's performance outside of controlled clinical trials, potentially improving care for those with oHCM. Participants in this observational study will be monitored while receiving mavacamten treatment. The study will keep track of any adverse events or serious adverse events that may occur, and the actions taken in response to these events. It will also measure the incidence and outcome of these events, providing a comprehensive understanding of the drug's safety profile in a real-world context.

Official TitleMavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan
Principal SponsorBristol-Myers Squibb
Study ContactBMS Study Connect Contact Center www.BMSStudyConnect.comMore contacts
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Aortic Valve DiseaseAortic Stenosis, SubvalvularAortic Valve StenosisCardiomyopathy, HypertrophicCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCardiomyopathies

Criteria

1 exclusion criteria prevent from participating
Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

CMIC Co., Ltd

Tokyo, JapanOpen CMIC Co., Ltd in Google Maps
Recruiting
One Study Center