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

Cardiomyopathy, Hypertrophic Clinical Trial

— MEMENTO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112743
• Other study ID #: CV027-1088
• Secondary ID: 2022-502316-36
• Status: Recruiting
• Phase: Phase 4
• Start date: January 24, 2024
• Est. completion date: October 30, 2026

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy

Intervention

Drug:
• Mavacamten
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0077	Ciudad De Cordoba	Cordoba
Australia	Local Institution - 0082	Darlinghurst	New South Wales
Australia	Local Institution - 0022	Herston	Queensland
Austria	Local Institution - 0032	Braunau am Inn	Upper Austria
Austria	Local Institution - 0028	Graz
Austria	Local Institution - 0057	Klagenfurt am Wörthersee	Kärnten
Austria	Local Institution - 0007	Wien
Austria	Local Institution - 0088	Wien
Belgium	Local Institution - 0084	Anderlecht	Brussels
Belgium	Local Institution - 0070	Bruxelles	Brussels
Belgium	Local Institution - 0092	Genk	Limburg
Belgium	Local Institution - 0069	Jette	Brussels
Belgium	Local Institution - 0083	Leuven	Vlaams Brabant
Belgium	Local Institution - 0071	Roeselare	West-Vlaanderen
Canada	Local Institution - 0004	Calgary	Alberta
Czechia	Local Institution - 0052	Brno
Czechia	Local Institution - 0016	Broumov	Královéhradecký Kraj
Czechia	Local Institution - 0050	Prague	Praha, Hlavní Mesto
Czechia	Local Institution - 0011	Praha 2	Praha, Hlavní Mesto
Czechia	Local Institution - 0053	Trinec	Moravskoslezský Kraj
Finland	Local Institution - 0073	Helsinki	Etelä-Suomen Lääni
Finland	Local Institution - 0072	Turku	Länsi-Suomen Lääni
France	Local Institution - 0031	Grenoble
France	Local Institution - 0014	Paris
France	Local Institution - 0026	Pessac
France	Local Institution - 0002	Rennes
Germany	Local Institution - 0040	Bad Oeynhausen	Nordrhein-Westfalen
Germany	Local Institution - 0023	Berlin
Germany	Local Institution - 0047	Giessen	Hessen
Germany	Local Institution - 0034	Göttingen	Niedersachsen
Greece	Local Institution - 0009	Athens
Greece	Local Institution - 0008	Athina	Attiki
Greece	Local Institution - 0059	Chaidari, Athens	Attiki
Greece	Local Institution - 0037	Heraklion
Greece	Local Institution - 0006	Thessaloniki
Greece	Local Institution - 0021	Thessaloniki
Hungary	Local Institution - 0020	Balatonfüred	Veszprém
Hungary	Local Institution - 0013	Budapest
Hungary	Local Institution - 0019	Budapest
Hungary	Local Institution - 0041	Budapest
Hungary	Local Institution - 0063	Budapest
Hungary	Local Institution - 0042	Pécs	Baranya
Hungary	Local Institution - 0054	Szeged	Csongrád
Italy	Local Institution - 0051	Arezzo
Italy	Local Institution - 0048	Firenze	Toscana
Italy	Local Institution - 0062	Massa	Toscana
Italy	Local Institution - 0038	Milano	Lombardia
Italy	Local Institution - 0060	Milano	Lombardia
Italy	Local Institution - 0056	Pavia	Lombardia
Poland	Local Institution - 0044	Katowice	Slaskie
Poland	Local Institution - 0012	Lódz
Poland	Local Institution - 0018	Warszawa	Mazowieckie
Poland	Local Institution - 0094	Warszawa	Mazowieckie
Poland	Local Institution - 0049	Zabrze	Slaskie
Spain	Local Institution - 0030	Barcelona
Spain	Local Institution - 0081	Madrid
Spain	Local Institution - 0089	Madrid
Spain	Local Institution - 0046	Malaga	Málaga
Spain	Local Institution - 0043	Palma de Mallorca	Baleares
Spain	Local Institution - 0045	Salamanca
Spain	Local Institution - 0039	Sevilla
Switzerland	Local Institution - 0036	Bern
Switzerland	Local Institution - 0061	Geneva
Switzerland	Local Institution - 0029	Lugano	Ticino (it)
Switzerland	Local Institution - 0055	Lugano	Ticino (it)
Switzerland	Local Institution - 0058	Luzern
United Kingdom	Local Institution - 0010	London
United States	Piedmont Hospital	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University Hospitals Cleveland Medical Center - 11100 Euclid Ave	Cleveland	Ohio
United States	Local Institution - 0091	Honolulu	Hawaii
United States	Houston Methodist Hospital	Houston	Texas
United States	Intermountain Medical Center	Murray	Utah
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Cedars Sinai Medical Center	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of left atrial volume index (LAVI) and left ventricular mass index (LVMI) 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	At week 48
Secondary	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
Secondary	Change from baseline in left atrial volume index (LAVI) at Week 48		At week 48
Secondary	Change from baseline in left ventricular mass index (LVMI) at Week 48		At week 48
Secondary	Incidence of major adverse cardiac events (MACE)		Up to 48 weeks
Secondary	Incidence of MACE-expanded events		Up to 48 weeks
Secondary	All-cause mortality		Up to 48 weeks
Secondary	Incidence of heart failure (HF) events		Up to 48 weeks
Secondary	Incidence of atrial fibrillation (AF)/atrial flutter		Up to 48 weeks
Secondary	Incidence of resuscitated cardiac arrest		Up to 48 weeks
Secondary	Incidence of ventricular tachyarrhythmias		Up to 48 weeks
Secondary	Incidence of nonvasovagal syncope and seizures		Up to 48 weeks
Secondary	Incidence of treatment emergent adverse events (TEAEs)		Up to 48 weeks
Secondary	Severity of TEAEs		Up to 48 weeks
Secondary	Incidence of treatment emergent serious adverse events (SAEs)		Up to 48 weeks
Secondary	Incidence of treatment emergent laboratory abnormalities		Up to 48 weeks
Secondary	Incidence of adverse events (AEs)		Up to 48 weeks
Secondary	Incidence of serious adverse events (SAEs)		Up to 48 weeks
Secondary	Incidence of AEs leading to discontinuation from study intervention		Up to 48 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting