Actively Recruiting
A Single-Arm Observational Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Led by Bristol-Myers Squibb · Updated on 2026-05-11
500
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world effectiveness of mavacamten treatment in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). This observational study aims to assess how mavacamten works in everyday clinical practice for patients with this heart condition, following current guidelines for diagnosis and treatment. The study is sponsored by Bristol-Myers Squibb and focuses on adult patients who have started or will start mavacamten based on clinical needs. Participants will receive mavacamten according to the product label and be monitored over time. The study includes retrospective and prospective enrollment, with follow-up visits scheduled at several time points up to 96 weeks. Researchers will observe changes in heart function, including left ventricular outflow tract (LVOT) gradients and symptom severity based on New York Heart Association (NYHA) class. During the study, participants will undergo regular evaluations using echocardiography to measure heart function and structure. Data on cardiac performance, symptom changes, and response to mavacamten will be collected at intervals such as weeks 4, 8, 12, 24, 36, 48, 72, and 96. The main outcomes include changes in LVOT gradients and NYHA class to understand mavacamten’s impact in real-world settings. Safety and treatment adherence will also be monitored throughout the study duration.
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
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older.
- Participants who have started or are scheduled to start mavacamten based on clinical needs.
- Diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines.
- Peak left ventricular outflow tract (LVOT) gradient of 30 mmHg or higher at rest or with provocation within 3 months prior to enrollment.
- Left ventricular ejection fraction (LVEF) of 55% or higher 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 traceable and at least one key follow-up time point is required.
- Signed informed consent form.
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.
- Currently treated with disopyramide or ranolazine within 14 days before enrollment or expected to take certain combinations of heart medications 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.
- Participation in other interventional clinical studies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks
Participants receive mavacamten according to the product label and clinical needs.
Visits at Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96
Trial Site Locations
Total: 15 locations
1
Local Institution - 0008
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
3
Peking University First Affiliated Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
4
Local Institution - 0009
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
5
The Second Afilliated Hospital of Hebei Medical University
Jiazhuang, Hebei, China, 050000
Actively Recruiting
6
Local Institution - 0003
Harbin, Heilongjiang, China, 150086
Not Yet Recruiting
7
Local Institution - 0007
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
8
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215002
Actively Recruiting
9
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Actively Recruiting
10
Local Institution - 0005
Dalian, Liaoning, China, 116011
Not Yet Recruiting
11
Local Institution - 0013
Xi'an, Shan3xi, China, 710061
Not Yet Recruiting
12
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
13
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
14
Local Institution - 0010
Jinan, China, 250012
Not Yet Recruiting
15
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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