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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06112743
Ethics application status
Date submitted
27/10/2023
Date registered
1/11/2023

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 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)
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

Experimental: Mavacamten -


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

Outcomes
Primary outcome [1] 0 0
Composite of maximum 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 maximum 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 HF events with systolic dysfunction
Timepoint [8] 0 0
Up to 48 weeks
Secondary outcome [9] 0 0
Incidence of atrial fibrillation (AF)/atrial flutter
Timepoint [9] 0 0
Up to 48 weeks
Secondary outcome [10] 0 0
Incidence of cardiovascular (CV) mortality
Timepoint [10] 0 0
Up to 48 weeks
Secondary outcome [11] 0 0
Incidence of ventricular tachyarrhythmias
Timepoint [11] 0 0
Up to 48 weeks
Secondary outcome [12] 0 0
Incidence of nonvasovagal syncope and seizures
Timepoint [12] 0 0
Up to 48 weeks
Secondary outcome [13] 0 0
Incidence of treatment emergent adverse events (TEAEs)
Timepoint [13] 0 0
Up to 48 weeks
Secondary outcome [14] 0 0
Severity of TEAEs
Timepoint [14] 0 0
Up to 48 weeks
Secondary outcome [15] 0 0
Incidence of treatment emergent serious adverse events (SAEs)
Timepoint [15] 0 0
Up to 48 weeks
Secondary outcome [16] 0 0
TEAEs leading to discontinuation from study intervention
Timepoint [16] 0 0
Up to 48 weeks
Secondary outcome [17] 0 0
TEAEs leading to laboratory abnormalities
Timepoint [17] 0 0
Up to 48 weeks

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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
31/12/2026
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0005 - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
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
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Switzerland
State/province [10] 0 0
Ticino (it)
Country [11] 0 0
Switzerland
State/province [11] 0 0
Geneva

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06112743