Mavacamten Real-World Effectiveness and Safety in Obstructive Hypertrophic Cardiomyopathy
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.
Data Collection
Collected from today forward - ProspectiveAortic Valve Disease+5
+ Aortic Stenosis, Subvalvular
+ Aortic Valve Stenosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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