What is mavacamten studying for hypertrophic cardiomyopathy?

Mavacamten is being studied to understand its effects on adults with symptomatic obstructive hypertrophic cardiomyopathy in real-world practice. This study aims to evaluate changes in heart function and symptoms over time. The research is sponsored by Bristol-Myers Squibb and focuses on patients treated according to current guidelines.

Who may be eligible for this hypertrophic cardiomyopathy clinical trial?

Adults aged 18 years and older diagnosed with obstructive hypertrophic cardiomyopathy who have symptoms classified as NYHA class II or III may be eligible. Participants must be starting or already taking mavacamten and have certain heart function measurements within specific ranges. Please review eligibility criteria for more details.

Is there any cost to participate in this hypertrophic cardiomyopathy clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years +

All Genders

ID07361289

Real-World Evaluation of Mavacamten Treatment in Chinese Adults with Obstructive Hypertrophic Cardiomyopathy

Led by Bristol-Myers Squibb · Updated on 2026-06-18

500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world effectiveness of mavacamten treatment in Chinese adults who have symptomatic obstructive hypertrophic cardiomyopathy HCM. The study aims to assess how mavacamten works for patients with this heart condition based on current clinical practice, following guidelines from leading heart associations. It focuses on adults aged 18 and older who have documented obstructive HCM and symptoms classified as New York Heart Association NYHA class II or III. Participants included are those who have started or are scheduled to start mavacamten treatment according to clinical needs. The treatment is given as directed by the product label. The study observes changes in heart function, specifically the left ventricular outflow tract LVOT gradient, and tracks participants for up to 96 weeks. Follow-up assessments occur at various points including weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 to monitor symptoms and heart performance. During the study, participants heart function is assessed using echocardiography and symptom classification by NYHA class. Researchers collect detailed clinical data such as heart structure and function measurements, medication doses, and LVOT gradients throughout the follow-up period. The main outcomes measured are changes in LVOT gradients at weeks 48 and 96, along with symptom improvements. This observational study involves no placebo or comparison group and records how patients respond to mavacamten in routine care over nearly two years.

CONDITIONS

Brief Title

A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants aged 18 years or older at the time of mavacamten prescription
Participants who have started or are scheduled to start mavacamten based on clinical needs
Diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines
Documented HCM diagnosis prior to enrollment
Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or with provocation within 3 months prior to enrollment
Left ventricular ejection fraction (LVEF) ≥ 55% as measured by resting transthoracic echocardiography within 3 months prior to enrollment
New York Heart Association (NYHA) class II or III symptoms within 3 months prior to enrollment
For retrospective participants, essential baseline and critical data must be available
At least one key follow-up time point required for inclusion

You will not qualify if you...

Known hypertrophic cardiomyopathy phenocopy diseases such as Fabry disease or amyloidosis
Expected to undergo major cardiac surgery during the study
Prior invasive septal reduction treatment within 6 months before enrollment or initial mavacamten prescription
Currently treated with disopyramide or ranolazine within 14 days before enrollment or initial mavacamten prescription
Expected to take certain drug combinations involving disopyramide, ranolazine, verapamil or diltiazem with beta-blockers during the study
Presence of other diseases that may prevent completion of 96 weeks follow-up
Using or expected to use moderate to strong CYP2C19 or CYP3A4 inhibitors or inducers during the study
Currently participating in other interventional clinical studies

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

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Real-World Evaluation of Mavacamten Treatment in Chinese Adults with Obstructive Hypertrophic Cardiomyopathy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria