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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112743

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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].

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy, Hypertrophic	Drug: Mavacamten Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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)

Anticipated Study Start Date :

Nov 20, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Nov 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mavacamten	Drug: Mavacamten Specified dose on specified days
Placebo Comparator: Placebo	Other: Placebo Specified dose on specified days

Arm

Intervention/Treatment

Experimental: Mavacamten

Drug: Mavacamten

Specified dose on specified days

Placebo Comparator: Placebo

Other: Placebo

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Composite of left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48 [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 LAVI from baseline A decrease of at least 5 g/m2 in LVMI from baseline

Secondary Outcome Measures

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 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]
All-cause mortality [Up to 48 weeks]
Incidence of heart failure (HF) events [Up to 48 weeks]
Incidence of atrial fibrillation (AF)/atrial flutter [Up to 48 weeks]
Incidence of resuscitated cardiac arrest [Up to 48 weeks]
Incidence of ventricular tachyarrhythmias [Up to 48 weeks]
Incidence of nonvasovagal syncope and seizures [Up to 48 weeks]
Incidence of treatment emergent adverse events (TEAEs) [Up to 48 weeks]
Severity of TEAEs [Up to 48 weeks]
Incidence of treatment emergent serious adverse events (SAEs) [Up to 48 weeks]
Incidence of treatment emergent laboratory abnormalities [Up to 48 weeks]
Incidence of adverse events (AEs) [Up to 48 weeks]
Incidence of serious adverse events (SAEs) [Up to 48 weeks]
Incidence of AEs leading to discontinuation from study intervention [Up to 48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	West Hollywood	California	United States	90048-1804
2	Queen's Heart Institute Honolulu	Honolulu	Hawaii	United States	96813-2414
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	University Hospitals Cleveland Medical Center - 11100 Euclid Ave	Cleveland	Ohio	United States	44106
5	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15224
6	Local Institution - 0028	Graz		Austria	8036
7	Local Institution - 0088	Wien		Austria	1090
8	Local Institution - 0092	Genk	Limburg	Belgium	3600
9	Local Institution - 0089	Madrid		Spain	28034
10	Local Institution - 0036	Bern		Switzerland	3010