Cardiomyopathy, Hypertrophic Clinical Trial
— MEMENTOOfficial 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)
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].
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom,
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 |
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