Clinical trial NCT06112743: A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiomyopathy, Hypertrophic
Keywords: BMS-986427
MYK-461
Mavacamten
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Camyzos
Cardiac Magnetic Resonance Imaging (CMR)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) \[New York Heart Association (NYHA) Functional Class II or III\].


Eligibility 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.

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.

Primary outcomes:
measure: Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
timeFrame: At week 48
Secondary outcomes:
measure: Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
timeFrame: At week 48
measure: Change from baseline in maximum left atrial volume index (LAVI) at Week 48
timeFrame: At week 48
measure: Change from baseline in left ventricular mass index (LVMI) at Week 48
timeFrame: At week 48
measure: Incidence of major adverse cardiac events (MACE)
timeFrame: Up to 48 weeks
measure: Incidence of MACE-expanded events
timeFrame: Up to 48 weeks
measure: All-cause mortality
timeFrame: Up to 48 weeks
measure: Incidence of heart failure (HF) events
timeFrame: Up to 48 weeks
measure: Incidence of HF events with systolic dysfunction
timeFrame: Up to 48 weeks
measure: Incidence of atrial fibrillation (AF)/atrial flutter
timeFrame: Up to 48 weeks
measure: Incidence of cardiovascular (CV) mortality
timeFrame: Up to 48 weeks
measure: Incidence of ventricular tachyarrhythmias
timeFrame: Up to 48 weeks
measure: Incidence of nonvasovagal syncope and seizures
timeFrame: Up to 48 weeks
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Up to 48 weeks
measure: Severity of TEAEs
timeFrame: Up to 48 weeks
measure: Incidence of treatment emergent serious adverse events (SAEs)
timeFrame: Up to 48 weeks
measure: TEAEs leading to discontinuation from study intervention
timeFrame: Up to 48 weeks
measure: TEAEs leading to laboratory abnormalities
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center - 1207 San Vicente Blvd
state: California
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Honolulu
country: United States
facility: Local Institution - 0091
state: Hawaii
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - 11100 Euclid Ave
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Murray
country: United States
facility: Local Institution - 0035
state: Utah
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Favaloro - Avenida Belgrano 1746
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires - ICBA - Blanco Encalada 1543
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Sanatorio Allende S.A.-Pedro Simón Laplace 5749
state: Cordoba
city: Rosario
country: Argentina
facility: Hospital Privado de Rosario
state: Santa FE
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution - 0082
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Herston
country: Australia
facility: Local Institution - 0022
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Klagenfurt am Wörthersee
country: Austria
facility: Local Institution - 0057
state: Kärnten
city: Braunau am Inn
country: Austria
facility: Local Institution - 0032
state: Upper Austria
city: Graz
country: Austria
facility: Local Institution - 0028
city: Wien
country: Austria
facility: Local Institution - 0088
city: Wien
country: Austria
facility: Local Institution - 0007
city: Anderlecht
country: Belgium
facility: Local Institution - 0084
state: Brussels
city: Bruxelles
country: Belgium
facility: Local Institution - 0070
state: Brussels
city: Jette
country: Belgium
facility: Local Institution - 0069
state: Brussels
city: Genk
country: Belgium
facility: Local Institution - 0092
state: Limburg
city: Leuven
country: Belgium
facility: Local Institution - 0083
state: Vlaams Brabant
city: Roeselare
country: Belgium
facility: Local Institution - 0071
state: West-Vlaanderen
city: Calgary
country: Canada
facility: Local Institution - 0004
state: Alberta
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
city: Broumov
country: Czechia
facility: Local Institution - 0016
state: Královéhradecký Kraj
city: Trinec
country: Czechia
facility: Local Institution - 0053
state: Moravskoslezský Kraj
city: Prague
country: Czechia
facility: Local Institution - 0050
state: Praha, Hlavní Mesto
city: Praha 2
country: Czechia
facility: Local Institution - 0011
state: Praha, Hlavní Mesto
city: Brno
country: Czechia
facility: Local Institution - 0052
city: Helsinki
country: Finland
facility: Local Institution - 0073
state: Etelä-Suomen Lääni
city: Turku
country: Finland
facility: Local Institution - 0072
state: Länsi-Suomen Lääni
city: Grenoble
country: France
facility: Local Institution - 0031
city: Paris
country: France
facility: Local Institution - 0014
city: Pessac
country: France
facility: Local Institution - 0026
city: Rennes
country: France
facility: Local Institution - 0002
city: Giessen
country: Germany
facility: Local Institution - 0047
state: Hessen
city: Göttingen
country: Germany
facility: Local Institution - 0034
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
facility: Local Institution - 0040
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Local Institution - 0023
city: Athina
country: Greece
facility: Local Institution - 0009
state: Attiki
city: Athina
country: Greece
facility: Local Institution - 0008
state: Attiki
city: Chaidari, Athens
country: Greece
facility: Local Institution - 0059
state: Attiki
city: Heraklion
country: Greece
facility: Local Institution - 0037
city: Thessaloniki
country: Greece
facility: Local Institution - 0006
city: Thessaloniki
country: Greece
facility: Local Institution - 0021
city: Pécs
country: Hungary
facility: Local Institution - 0042
state: Baranya
city: Szeged
country: Hungary
facility: Local Institution - 0054
state: Csongrád
city: Balatonfüred
country: Hungary
facility: Local Institution - 0020
state: Veszprém
city: Budapest
country: Hungary
facility: Local Institution - 0019
city: Budapest
country: Hungary
facility: Local Institution - 0013
city: Budapest
country: Hungary
facility: Local Institution - 0041
city: Budapest
country: Hungary
facility: Local Institution - 0063
city: Milano
country: Italy
facility: Local Institution - 0038
state: Lombardia
city: Milano
country: Italy
facility: Local Institution - 0060
state: Lombardia
city: Pavia
country: Italy
facility: Local Institution - 0056
state: Lombardia
city: Firenze
country: Italy
facility: Local Institution - 0048
state: Toscana
city: Pisa
country: Italy
facility: Local Institution - 0062
state: Toscana
city: Arezzo
country: Italy
facility: Local Institution - 0051
city: Warszawa
country: Poland
facility: Local Institution - 0018
state: Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0094
state: Mazowieckie
city: Katowice
country: Poland
facility: Local Institution - 0044
state: Slaskie
city: Zabrze
country: Poland
facility: Local Institution - 0049
state: Slaskie
city: Bialystok
country: Poland
facility: Local Institution - 0064
city: Lódz
country: Poland
facility: Local Institution - 0012
city: Palma de Mallorca
country: Spain
facility: Local Institution - 0043
state: Baleares
city: Malaga
country: Spain
facility: Local Institution - 0046
state: Málaga
city: Barcelona
country: Spain
facility: Local Institution - 0030
city: Madrid
country: Spain
facility: Local Institution - 0089
city: Madrid
country: Spain
facility: Local Institution - 0081
city: Salamanca
country: Spain
facility: Local Institution - 0045
city: Sevilla
country: Spain
facility: Local Institution - 0039
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital (LUKS)
state: Luzern (de)
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
state: Ticino (it)
city: Lugano
country: Switzerland
facility: Local Institution - 0055
state: Ticino (it)
city: Bern
country: Switzerland
facility: Local Institution - 0036
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Zürich (de)
country: Switzerland
facility: Universitätsspital Zürich
city: Belfast
country: United Kingdom
facility: Local Institution - 0027
state: Antrim
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: Yorkshire
city: London
country: United Kingdom
facility: Local Institution - 0010
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: