Menu
Recruiting NCT07383025

Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

— Observational Obstructive Hypertrophic Cardiomyopathy (oHCM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mavacamten.
Who it may be relevant to
Registry conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan

Overview

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan

Interventions

  • Drug Mavacamten
    According to the product label

Primary outcome measures

  • Incidence of adverse events (AEs) and/or serious AEs (SAEs) [Time frame: Up to 52 weeks]
  • Actions taken after adverse events (AEs) and/or serious AEs (SAEs) [Time frame: Up to 52 weeks]
  • Outcome of adverse events (AEs) and/or serious AEs (SAEs) [Time frame: Up to 52 weeks]

Eligibility criteria

Inclusion criteria

  • All obstructive hypertrophic cardiomyopathy (oHCM) patients who initiate treatment with Mavacamten of the approved indications at medical institutions in Japan during enrollment period will be enrolled in this regulatory post-marketing surveillance (PMS) study

Exclusion criteria

  • Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Japan · 1 center
  • CMIC Co., Ltd — Tokyo

Identifiers

NCT: NCT07383025 · CV027-1081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗