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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: First line of the email MUST contain NCT # and Site #.
Studijní záloha kontaktů
- Jméno: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonní číslo: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studijní místa
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Shanghai, Čína
- Fudan University Zhongshan Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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 |
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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 |
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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 |
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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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Number of participants in each study cohort
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Časové okno: 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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New York Heart Association (NYHA) functional class classification as assessed by the treating physician
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: Up to 15 months
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Up to 15 months
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Number of participants reaching mavacamten maintenance dose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to 15 months
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Up to 15 months
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Time (days) from Index Date to mavacamten discontinuation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CV027-1262
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