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

NCT ID: NCT06112743

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2026-07-09

Brief Summary

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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

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Conditions

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Cardiomyopathy, Hypertrophic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mavacamten

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Interventions

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Mavacamten

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0087

West Hollywood, California, United States

Site Status

Local Institution - 0003

Atlanta, Georgia, United States

Site Status

Local Institution - 0093

Boston, Massachusetts, United States

Site Status

Local Institution - 0090

Cleveland, Ohio, United States

Site Status

Local Institution - 0086

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0017

Houston, Texas, United States

Site Status

Local Institution - 0035

Murray, Utah, United States

Site Status

Local Institution - 0076

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0075

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0079

Pilar, Buenos Aires, Argentina

Site Status

Local Institution - 0077

Córdoba, Córdoba Province, Argentina

Site Status

Local Institution - 0074

Rosario, Santa Fe Province, Argentina

Site Status

Local Institution - 0080

Buenos Aires, , Argentina

Site Status

Local Institution - 0015

Camperdown, New South Wales, Australia

Site Status

Local Institution - 0085

Chermside, Queensland, Australia

Site Status

Local Institution - 0005

Melbourne, Victoria, Australia

Site Status

Local Institution - 0001

Montreal, Quebec, Canada

Site Status

Local Institution - 0068

Québec, Quebec, Canada

Site Status

Local Institution - 0058

Lucerne, Luzern (de), Switzerland

Site Status

Local Institution - 0029

Lugano, Ticino (it), Switzerland

Site Status

Local Institution - 0061

Geneva, , Switzerland

Site Status

Local Institution - 0024

Zürich (de), , Switzerland

Site Status

Local Institution - 0025

Leeds, Yorkshire, United Kingdom

Site Status

Countries

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United States Argentina Australia Canada Switzerland United Kingdom

Related Links

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Other Identifiers

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CV027-1088

Identifier Type: -

Identifier Source: org_study_id

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