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

September 15, 2026 updated by: Bristol-Myers Squibb

MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)

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].

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1199
        • Local Institution - 0080
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1093
        • Local Institution - 0076
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1428ART
        • Local Institution - 0075
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Local Institution - 0079
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5021FPQ
        • Local Institution - 0077
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000GAP
        • Local Institution - 0074
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0015
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Local Institution - 0085
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0005
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Local Institution - 0001
      • Québec, Quebec, Canada, G1V 4G5
        • Local Institution - 0068
  • Switzerland
      • Geneva, Switzerland, 1205
        • Local Institution - 0061
      • Zürich (de), Switzerland, 8091
        • Local Institution - 0024
    • Luzern (de)
      • Lucerne, Luzern (de), Switzerland, 6000
        • Local Institution - 0058
    • Ticino (it)
      • Lugano, Ticino (it), Switzerland, 6900
        • Local Institution - 0029
  • United Kingdom
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS1 3EX
        • Local Institution - 0025
  • United States
    • California
      • West Hollywood, California, United States, 90048-1804
        • Local Institution - 0087
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Local Institution - 0003
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0093
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0090
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212-4756
        • Local Institution - 0086
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0017
    • Utah
      • Murray, Utah, United States, 84107-5701
        • Local Institution - 0035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mavacamten
Drug: Mavacamten
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
Time Frame: 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 Outcome Measures

Outcome Measure
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
Time Frame: At week 48
At week 48
Change from baseline in left ventricular mass index (LVMI) at Week 48
Time Frame: At week 48
At week 48
Incidence of major adverse cardiac events (MACE)
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of MACE-expanded events
Time Frame: Up to 48 weeks
Up to 48 weeks
All-cause mortality
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of heart failure (HF) events
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of atrial fibrillation (AF)/atrial flutter
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of ventricular tachyarrhythmias
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of nonvasovagal syncope and seizures
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: Up to 48 weeks
Up to 48 weeks
Severity of TEAEs
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)
Time Frame: Up to 48 weeks
Up to 48 weeks
Change from baseline in maximum left atrial volume index (LAVI) at Week 48
Time Frame: At week 48
At week 48
Incidence of HF events with systolic dysfunction
Time Frame: Up to 48 weeks
Up to 48 weeks
Incidence of cardiovascular (CV) mortality
Time Frame: Up to 48 weeks
Up to 48 weeks
TEAEs leading to discontinuation from study intervention
Time Frame: Up to 48 weeks
Up to 48 weeks
TEAEs leading to laboratory abnormalities
Time Frame: Up to 48 weeks
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Actual)

July 16, 2026

Study Completion (Estimated)

June 10, 2027

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1088
  • 2022-502316-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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