A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT06112743 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: CV027-1088
• Study Type: interventional
• Target: 63
• Locations: 6 countries
• Sites: 23

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) \[New York Heart Association (NYHA) Functional Class II or III\].

Conditions

Cardiomyopathy, Hypertrophic

Keywords

BMS-986427; MYK-461; Mavacamten; Obstructive Hypertrophic Cardiomyopathy (oHCM); Camyzos; Cardiac Magnetic Resonance Imaging (CMR)

Outcome Measures

Primary Outcomes (1)

• 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 (17)

• 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

• Change from baseline in left ventricular mass index (LVMI) at Week 48

  At week 48

• Incidence of major adverse cardiac events (MACE)

  Up to 48 weeks

• Incidence of MACE-expanded events

  Up to 48 weeks

Study Arms (1)

Mavacamten

EXPERIMENTAL

Drug: Mavacamten

Interventions

Mavacamten DRUG

Specified dose on specified days

Mavacamten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (23)

Local Institution - 0087

West Hollywood, California, 90048-1804, United States

Location

Local Institution - 0003

Atlanta, Georgia, 30309, United States

Location

Local Institution - 0093

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0090

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0086

Pittsburgh, Pennsylvania, 15212-4756, United States

Location

Local Institution - 0017

Houston, Texas, 77030, United States

Location

Local Institution - 0035

Murray, Utah, 84107-5701, United States

Location

Local Institution - 0076

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1093, Argentina

Location

Local Institution - 0075

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1428ART, Argentina

Location

Local Institution - 0079

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Local Institution - 0077

Córdoba, Córdoba Province, X5021FPQ, Argentina

Location

Local Institution - 0074

Rosario, Santa Fe Province, S2000GAP, Argentina

Location

Local Institution - 0080

Buenos Aires, 1199, Argentina

Location

Local Institution - 0015

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0085

Chermside, Queensland, 4032, Australia

Location

Local Institution - 0005

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0001

Montreal, Quebec, H1T 1C8, Canada

Location

Local Institution - 0068

Québec, Quebec, G1V 4G5, Canada

Location

Local Institution - 0058

Lucerne, Luzern (de), 6000, Switzerland

Location

Local Institution - 0029

Lugano, Ticino (it), 6900, Switzerland

Location

Local Institution - 0061

Geneva, 1205, Switzerland

Location

Local Institution - 0024

Zürich (de), 8091, Switzerland

Location

Local Institution - 0025

Leeds, Yorkshire, LS1 3EX, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 9, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (7); AU (3); CA (2); CH (4); GB (1); AR (6)