A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
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. Basic parameters: from 19 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
- South Korea
- 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
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Overview
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.
Interventions
- Drug Mavacamten
According to approved product label
Primary outcome measures
- Number of participants with adverse events [Time frame: Up to 12 months]
Eligibility criteria
Inclusion criteria
- Adult participants 19 years of age or older
- Participants who receive mavacamten according to the approved product label
- Participants who sign the informed consent form
Exclusion criteria
- Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
- Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 2 centers
- Local Institution - 0001 — Seoul
- Novotech Laboratory Korea Co., Ltd. — Seoul
Identifiers
NCT: NCT06146660 · CV027-1089