Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Number of participants in each study cohort
Study Overview
Brief Summary
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must meet all of the following criteria to be included:
- Diagnosis: Have a documented diagnosis of obstructive hypertrophic cardiomyopathy (oHCM), identified by the corresponding International Classification of Diseases (ICD)-10 codes in the medical record system.
- Medication Exposure: Have a first-ever recorded prescription for Mavacamten within the Patient Identification Period (24 October 2024 to 31 March 2026). This date is defined as the Index Date.
- Age: Be ≥ 18 years of age at the Index Date.
- Treatment Continuity: Have at least two valid clinical records of any type (e.g., outpatient visit, inpatient encounter, prescription refill, laboratory test, or echocardiogram) after the Index Date.
Exclusion Criteria
- Participants meeting any of the following criteria will be excluded:
- Prior Use of Study Drug: Have any documented history of Mavacamten use (based on medical history records, prescription records, or clinical notes) at any time prior to the Index Date.
Arms & Interventions
Category A1. Sustained Monotherapy
Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up.
Intervention: Mavacamten (Drug)
Category A2. Treatment Intensification
Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up.
Intervention: Mavacamten (Drug)
Category B1. Stable Combination Therapy at Initiation
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up.
Intervention: Mavacamten (Drug)
Category B2. Treatment Simplification
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and subsequently discontinued all background oHCM medications, resulting in mavacamten monotherapy.
Intervention: Mavacamten (Drug)
Category C. Complex/Unclassifiable
Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups.
Intervention: Mavacamten (Drug)
Outcomes
Primary Outcomes
Number of participants in each study cohort
Time Frame: Baseline and months 1, 2, 3, 6, 9, 12 and 15
Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Secondary Outcomes
- Number of participants that discontinued mavacamten treatment(Up to 15 months)
- Time (days) from Index Date to mavacamten discontinuation(Day 1 and up to 15 months)
- Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography(Baseline and at months 1, 2, 3, 6, 9, 12 and 15)
- Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class(Baseline and at months 1, 2, 3, 6, 9, 12 and 15)
- New York Heart Association (NYHA) functional class classification as assessed by the treating physician(Baseline and at months 1, 2, 3, 6, 9, 12 and 15)
- Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography(Baseline and at months 1, 2, 3, 6, 9, 12 and 15)
- Change from baseline in E/e' ratio assessed by transthoracic echocardiography(Baseline and months 1, 2, 3, 6, 9, 12 and 15)
- Prescribed mavacamten dose (mg)(Day 1 and months 1, 2, 3, 6, 9, 12 and 15)
- Prescribed mavacamten maintenance dose (mg) during follow-up(Up to 15 months)
- Number of participants reaching mavacamten maintenance dose(Up to 15 months)
- Number of participants whose prescribed mavacamten dose changed during the observation period(Day 1 and and up to 15 months)
- Time (days) from Index Date to achieving mavacamten maintenance dose(Day 1 and up to 15 months)
- Duration of mavacamten treatment during follow-up(Day 1 and up to 15 months)
- Prior hypertrophic cardiomyopathy (oHCM) medication drug class(Baseline and up to 15 months)
- Prior hypertrophic cardiomyopathy (oHCM) medication dose(Baseline and up to 15 months)
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT07846059
- Other Study IDs
- CV027-1262
Dates
- First Submitted
- (7 days ago)
- First Posted
- (yesterday)
- Primary Completion
- (in 6 months)
- Study Completion
- (in 7 months)
- Last Verified
- (29 days ago)
- Last updated
- (yesterday)
Regulatory & Sharing
- FDA Regulated Drug
- Yes
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No