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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: First line of the email MUST contain NCT # and Site #.
Studie Contact Back-up
- Naam: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefoonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studie Locaties
-
-
-
Shanghai, China
- Fudan University Zhongshan Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of participants in each study cohort
Tijdsspanne: Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
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
Tijdsspanne: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
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
Tijdsspanne: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Tijdsspanne: 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
Tijdsspanne: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Tijdsspanne: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Tijdsspanne: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Tijdsspanne: Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Prescribed mavacamten dose (mg)
Tijdsspanne: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
|
Day 1 and months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Prescribed mavacamten maintenance dose (mg) during follow-up
Tijdsspanne: Up to 15 months
|
Up to 15 months
|
|
|
Number of participants reaching mavacamten maintenance dose
Tijdsspanne: Up to 15 months
|
Up to 15 months
|
|
|
Number of participants whose prescribed mavacamten dose changed during the observation period
Tijdsspanne: Day 1 and and up to 15 months
|
Day 1 and and up to 15 months
|
|
|
Time (days) from Index Date to achieving mavacamten maintenance dose
Tijdsspanne: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
|
Number of participants that discontinued mavacamten treatment
Tijdsspanne: Up to 15 months
|
Up to 15 months
|
|
|
Time (days) from Index Date to mavacamten discontinuation
Tijdsspanne: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
|
Duration of mavacamten treatment during follow-up
Tijdsspanne: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
|
Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Tijdsspanne: 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
Tijdsspanne: Baseline and up to 15 months
|
Dose of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CV027-1262
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .