Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy (REMAP-HCM)
Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: First line of the email MUST contain NCT # and Site #.
Copia de seguridad de contactos de estudio
- Nombre: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Número de teléfono: 855-907-3286
- Correo electrónico: Clinical.Trials@bms.com
Ubicaciones de estudio
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Shanghai, Porcelana
- Fudan University Zhongshan Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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:
(1) 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Category A1. Sustained Monotherapy
Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up. |
As per product label |
|
Category A2. Treatment Intensification
Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up. |
As per product label |
|
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. |
As per product label |
|
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. |
As per product label |
|
Category C. Complex/Unclassifiable
Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups. |
As per product label |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of participants in each study cohort
Periodo de tiempo: Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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New York Heart Association (NYHA) functional class classification as assessed by the treating physician
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Periodo de tiempo: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Periodo de tiempo: Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Prescribed mavacamten dose (mg)
Periodo de tiempo: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
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Day 1 and months 1, 2, 3, 6, 9, 12 and 15
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Prescribed mavacamten maintenance dose (mg) during follow-up
Periodo de tiempo: Up to 15 months
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Up to 15 months
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Number of participants reaching mavacamten maintenance dose
Periodo de tiempo: Up to 15 months
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Up to 15 months
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Number of participants whose prescribed mavacamten dose changed during the observation period
Periodo de tiempo: Day 1 and and up to 15 months
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Day 1 and and up to 15 months
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Time (days) from Index Date to achieving mavacamten maintenance dose
Periodo de tiempo: Day 1 and up to 15 months
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Day 1 and up to 15 months
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Number of participants that discontinued mavacamten treatment
Periodo de tiempo: Up to 15 months
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Up to 15 months
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Time (days) from Index Date to mavacamten discontinuation
Periodo de tiempo: Day 1 and up to 15 months
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Day 1 and up to 15 months
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Duration of mavacamten treatment during follow-up
Periodo de tiempo: Day 1 and up to 15 months
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Day 1 and up to 15 months
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Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Periodo de tiempo: Baseline and up to 15 months
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Drug class of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
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Prior hypertrophic cardiomyopathy (oHCM) medication dose
Periodo de tiempo: Baseline and up to 15 months
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Dose of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CV027-1262
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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