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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06112743




Registration number
NCT06112743
Ethics application status
Date submitted
27/10/2023
Date registered
1/11/2023
Date last updated
13/05/2024

Titles & IDs
Public title
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Scientific title
MEMENTO - A Phase 3b/4, Randomized, Double-blind, Placebo-controlled 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)
Secondary ID [1] 0 0
2022-502316-36
Secondary ID [2] 0 0
CV027-1088
Universal Trial Number (UTN)
Trial acronym
MEMENTO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy, Hypertrophic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mavacamten
Other interventions - Placebo

Experimental: Mavacamten -

Placebo Comparator: Placebo -


Treatment: Drugs: Mavacamten
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
Timepoint [1] 0 0
At week 48
Secondary outcome [1] 0 0
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
Timepoint [1] 0 0
At week 48
Secondary outcome [2] 0 0
Change from baseline in left atrial volume index (LAVI) at Week 48
Timepoint [2] 0 0
At week 48
Secondary outcome [3] 0 0
Change from baseline in left ventricular mass index (LVMI) at Week 48
Timepoint [3] 0 0
At week 48
Secondary outcome [4] 0 0
Incidence of major adverse cardiac events (MACE)
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Incidence of MACE-expanded events
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
All-cause mortality
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
Incidence of heart failure (HF) events
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Incidence of atrial fibrillation (AF)/atrial flutter
Timepoint [8] 0 0
Up to 48 weeks
Secondary outcome [9] 0 0
Incidence of resuscitated cardiac arrest
Timepoint [9] 0 0
Up to 48 weeks
Secondary outcome [10] 0 0
Incidence of ventricular tachyarrhythmias
Timepoint [10] 0 0
Up to 48 weeks
Secondary outcome [11] 0 0
Incidence of nonvasovagal syncope and seizures
Timepoint [11] 0 0
Up to 48 weeks
Secondary outcome [12] 0 0
Incidence of treatment emergent adverse events (TEAEs)
Timepoint [12] 0 0
Up to 48 weeks
Secondary outcome [13] 0 0
Severity of TEAEs
Timepoint [13] 0 0
Up to 48 weeks
Secondary outcome [14] 0 0
Incidence of treatment emergent serious adverse events (SAEs)
Timepoint [14] 0 0
Up to 48 weeks
Secondary outcome [15] 0 0
Incidence of treatment emergent laboratory abnormalities
Timepoint [15] 0 0
Up to 48 weeks
Secondary outcome [16] 0 0
Incidence of adverse events (AEs)
Timepoint [16] 0 0
Up to 48 weeks
Secondary outcome [17] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [17] 0 0
Up to 48 weeks
Secondary outcome [18] 0 0
Incidence of AEs leading to discontinuation from study intervention
Timepoint [18] 0 0
Up to 48 weeks

Eligibility
Key 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 mm Hg and = 50 mm Hg after
Valsalva or after exercise

- Left ventricular ejection fraction (LVEF) = 55% at rest

- New York Heart Association (NYHA) functional class II or III symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Note: Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0082 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0022 - Herston
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Austria
State/province [10] 0 0
Kärnten
Country [11] 0 0
Austria
State/province [11] 0 0
Upper Austria
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Limburg
Country [16] 0 0
Belgium
State/province [16] 0 0
Vlaams Brabant
Country [17] 0 0
Belgium
State/province [17] 0 0
West-Vlaanderen
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Czechia
State/province [19] 0 0
Královéhradecký Kraj
Country [20] 0 0
Czechia
State/province [20] 0 0
Moravskoslezský Kraj
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha, Hlavní Mesto
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Finland
State/province [23] 0 0
Etelä-Suomen Lääni
Country [24] 0 0
Finland
State/province [24] 0 0
Länsi-Suomen Lääni
Country [25] 0 0
France
State/province [25] 0 0
Grenoble
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Pessac
Country [28] 0 0
France
State/province [28] 0 0
Rennes
Country [29] 0 0
Germany
State/province [29] 0 0
Hessen
Country [30] 0 0
Germany
State/province [30] 0 0
Niedersachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Nordrhein-Westfalen
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Greece
State/province [33] 0 0
Attiki
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Heraklion
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaloniki
Country [37] 0 0
Hungary
State/province [37] 0 0
Baranya
Country [38] 0 0
Hungary
State/province [38] 0 0
Csongrád
Country [39] 0 0
Hungary
State/province [39] 0 0
Veszprém
Country [40] 0 0
Hungary
State/province [40] 0 0
Budapest
Country [41] 0 0
Italy
State/province [41] 0 0
Lombardia
Country [42] 0 0
Italy
State/province [42] 0 0
Toscana
Country [43] 0 0
Italy
State/province [43] 0 0
Arezzo
Country [44] 0 0
Poland
State/province [44] 0 0
Mazowieckie
Country [45] 0 0
Poland
State/province [45] 0 0
Slaskie
Country [46] 0 0
Poland
State/province [46] 0 0
Lódz
Country [47] 0 0
Spain
State/province [47] 0 0
Baleares
Country [48] 0 0
Spain
State/province [48] 0 0
Málaga
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Salamanca
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Switzerland
State/province [53] 0 0
Ticino (it)
Country [54] 0 0
Switzerland
State/province [54] 0 0
Bern
Country [55] 0 0
Switzerland
State/province [55] 0 0
Geneva
Country [56] 0 0
Switzerland
State/province [56] 0 0
Luzern
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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].
Trial website
https://clinicaltrials.gov/ct2/show/NCT06112743
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06112743