Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy
Official title: CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Run by Bristol-Myers Squibb · NCT06146660 · Data updated 2026-11-12
This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Status | Recruiting |
| Started | July 24, 2024 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06146660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 years or older who are receiving mavacamten for symptomatic obstructive hypertrophic cardiomyopathy.
✕Probably not a fit
Patients who are prescribed mavacamten for unapproved therapeutic indications or those for whom it is contraindicated will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the real-world safety of mavacamten in adult patients suffering from symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in Korea. Participants will be enrolled if they receive at least one dose of mavacamten as per the approved product label. The study will gather data on the safety profile of the medication in a real-world setting, providing insights into its effects and tolerability among the target population.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety of mavacamten, potentially improving treatment options for patients with obstructive hypertrophic cardiomyopathy.
How similar studies have gone: While this study focuses on the safety of mavacamten in a specific population, similar studies have shown promising results in assessing the safety and efficacy of treatments for hypertrophic cardiomyopathy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea Recruiting -
Local Institution - 0001
Seoul, South Korea Terminated
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten
This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.
-
Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy
This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.
-
Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy
This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.
-
Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US
See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.
-
Mavacamten treatment for obstructive hypertrophic cardiomyopathy in Japan
This project will try mavacamten in patients in Japan with obstructive hypertrophic cardiomyopathy to see if it works well and is safe during routine care.
-
Ademetionine treatment for obstructive hypertrophic cardiomyopathy
This study will test whether taking ademetionine can improve exercise capacity, symptoms, heart structure and quality of life in adults with obstructive hypertrophic cardiomyopathy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.