A Study to Evaluate Mavacamten Impact on Myocardial Struc... | NCT06112743

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2024Actual

Primary Completion Date

Jul 9, 2026Estimated

Completion Date

Jul 9, 2026Estimated

First Submitted Date

Oct 27, 2023

First Submission Date that Met QC Criteria

Oct 27, 2023

First Posted Date

Nov 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Label	Type	Description	Intervention Names
Mavacamten	Experimental		Drug: Mavacamten

Name	Type	Description	Arm Group Labels	Other Names
Mavacamten	Drug	Specified dose on specified days	Mavacamten

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48	Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: A decrease of at least 5 mL/m2 in maximum LAVI from baseline A decrease of at least 5 g/m2 in LVMI from baseline	At week 48

Secondary Outcomes

Measure	Description	Time Frame
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48		At week 48
Change from baseline in maximum left atrial volume index (LAVI) at Week 48		At week 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
New York Heart Association (NYHA) functional class II or III symptoms.

Exclusion Criteria

A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
Documented obstructive coronary artery disease or history of myocardial infarction.
A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
Other protocol-defined inclusion/exclusion criteria apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0087		West Hollywood	California	90048-1804	United States
Local Institution - 0003

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular
D001024	Aortic Valve Stenosis
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases