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

NCT07361289 | Recruiting FDA Drug

• 1 other identifier: CV027-1210
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to assess the effectiveness of mavacamten treatment in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in real-world clinical practice

Conditions

Hypertrophic Cardiomyopathy

Keywords

Obstructive hypertrophic cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Valsalva left ventricular outflow tract (LVOT) gradient

  Week 48, Week 96

• Change from baseline in resting valsalva left ventricular outflow tract (LVOT) gradient

  Week 48, Week 96

Secondary Outcomes (3)

• Change from baseline in New York Heart Association (NYHA) class

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96

• Number and proportion of participants with a resting/provoked left ventricular outflow tract (LVOT) gradient < 30/50 mmHg

  Week 12, Week 36, Week 48, Week 72, and Week 96

• Number and proportion of participants achieving complete response (defined as all left ventricular outflow tract (LVOT) gradients < 30 mmHg and New York Heart Association (NYHA) Class I)

  Week 12, Week 36, Week 48, Week 72, and Week 96

Study Arms (1)

Cohort 1

Participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy that have received mavacamten treatment in China

You may qualify if:

• Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender.
• Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese guidelines for diagnosis and treatment of patients with hypertrophic cardiomyopathy, i.e., satisfy criteria below:
• Has unexplained left ventricular (LV) hypertrophy with non-dilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy) in the most recent medical record within 3 months prior to enrollment, and
• Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or with provocation in the most recent medical record within 3 months prior to enrollment as assessed by echocardiography.
• Has documented left ventricular ejection fraction (LVEF) ≥ 55%, as measured by resting transthoracic echocardiography (TTE) in the most recent medical record within 3 months prior to enrollment.
• New York Heart Association (NYHA) class II or III symptoms in the most recent medical record within 3 months prior to enrollment.
• Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamten (for whom enrolled prospectively) based on clinical therapeutic needs.
• For participants enrolled retrospectively, must have traceable essential baseline information (including age, gender, resting LVOT peak gradient, Valsalva LVOT peak gradient, LVEF, indices of cardiac structure, systolic and diastolic function, cardiac biomarkers, NYHA functional class) and critical data (including resting and Valsalva LVOT gradient, LVEF, cardiac structure, systolic and diastolic function, dose of mavacamten) at key follow-up time points that have been completed.
• Voluntary sign informed consent form.

You may not qualify if:

• Known HCM phenocopy disease (e.g., Fabry disease, amyloidosis).
• Participants who are expected to undergo major cardiac surgery during the study.
• Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\] or septal radiofrequency ablation) within 6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription); participants with an unsuccessful myectomy or percutaneous ASA or septal radiofrequency ablation performed \>6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription) may be enrolled.
• Currently treated with disopyramide or ranolazine (within 14 days prior to enrollment \[participants enrolled retrospectively: within 14 days prior to initial mavacamten prescription\]) or participants who are expected to be taking disopyramide, ranolazine, verapamil in combination with β-receptor blockers, or diltiazem in combination with β-receptor blockers during the study.
• Presence of other diseases that may affect completion of 96 weeks follow-up as assessed by the investigator.
• Participants who are using or are expected to be using moderate to strong CYP2C19 inhibitors/inducers, or strong CYP3A4 inhibitors, moderate to strong CYP3A4 inducers during the study.
• Participants who are participating in other interventional clinical studies.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (15)

Local Institution - 0008

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Peking University First Affiliated Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Local Institution - 0009

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

The Second Afilliated Hospital of Hebei Medical University

Jiazhuang, Hebei, 050000, China

RECRUITING

Local Institution - 0003

Harbin, Heilongjiang, 150086, China

NOT YET RECRUITING

Local Institution - 0007

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215002, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Local Institution - 0005

Dalian, Liaoning, 116011, China

NOT YET RECRUITING

Local Institution - 0013

Xi'an, Shan3xi, 710061, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Local Institution - 0010

Jinan, 250012, China

NOT YET RECRUITING

Local Institution - 0011

Shanghai, 200032, China

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 23, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): August 22, 2028
• Study Completion (Estimated): August 28, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)