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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
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Shanghai, Kina
- Fudan University Zhongshan Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants in each study cohort
Tidsramme: Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
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
Tidsramme: 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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|
Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Tidsramme: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Tidsramme: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
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
Tidsramme: 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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Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Tidsramme: 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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Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Tidsramme: 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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Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Tidsramme: 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)
Tidsramme: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
|
Day 1 and months 1, 2, 3, 6, 9, 12 and 15
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Prescribed mavacamten maintenance dose (mg) during follow-up
Tidsramme: Up to 15 months
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Up to 15 months
|
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Number of participants reaching mavacamten maintenance dose
Tidsramme: Up to 15 months
|
Up to 15 months
|
|
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Number of participants whose prescribed mavacamten dose changed during the observation period
Tidsramme: Day 1 and and up to 15 months
|
Day 1 and and up to 15 months
|
|
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Time (days) from Index Date to achieving mavacamten maintenance dose
Tidsramme: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
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Number of participants that discontinued mavacamten treatment
Tidsramme: Up to 15 months
|
Up to 15 months
|
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Time (days) from Index Date to mavacamten discontinuation
Tidsramme: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
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Duration of mavacamten treatment during follow-up
Tidsramme: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
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Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Tidsramme: Baseline and up to 15 months
|
Drug class of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
|
Prior hypertrophic cardiomyopathy (oHCM) medication dose
Tidsramme: Baseline and up to 15 months
|
Dose of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CV027-1262
Plan for individuelle deltagerdata (IPD)
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