Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
The study will include adults in China diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiated mavacamten treatment between 24 October 2024 and 31 March 2026.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Mavacamten
DrugAs per product label
Treatment groups
800 Participants
are divided into 5 treatment groupsGroup A: Category A1. Sustained Monotherapy1 intervention
Group B: Category A2. Treatment Intensification1 intervention
Group C: Category B1. Stable Combination Therapy at Initiation1 intervention
Group D: Category B2. Treatment Simplification1 intervention
Group E: Category C. Complex/Unclassifiable1 intervention
Trial outcomes
Primary outcomes
1
Number of participants in each study cohort
Time frame
Baseline and months 1, 2, 3, 6, 9, 12 and 152
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 153
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 15Secondary outcomes
1
Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Time frame
Baseline and at months 1, 2, 3, 6, 9, 12 and 152
New York Heart Association (NYHA) functional class classification as assessed by the treating physician
Time frame
Baseline and at months 1, 2, 3, 6, 9, 12 and 153
Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Time frame
Baseline and at months 1, 2, 3, 6, 9, 12 and 154
Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Time frame
Baseline and at months 1, 2, 3, 6, 9, 12 and 15Sponsors and contacts
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Source ClinicalTrials.gov
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