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

Phase 4

Recruiting

• Conditions: Cardiomyopathy, Hypertrophic
• Interventions: Drug: Mavacamten

• Registration Number: NCT06112743
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Study Start: 2024-01-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mavacamten	Mavacamten	-

Primary Outcome Measures

Name	Time	Method
Composite of maximum 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 maximum LAVI from baseline; * A decrease of at least 5 g/m2 in LVMI from baseline

Secondary Outcome Measures

Name	Time	Method
Change from baseline in maximum left atrial volume index (LAVI) at Week 48	At week 48
Incidence of MACE-expanded events	Up to 48 weeks
Incidence of heart failure (HF) events	Up to 48 weeks
Incidence of HF events with systolic dysfunction	Up to 48 weeks
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 ventricular tachyarrhythmias	Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)	Up to 48 weeks
TEAEs leading to laboratory abnormalities	Up to 48 weeks
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
All-cause mortality	Up to 48 weeks
Incidence of atrial fibrillation (AF)/atrial flutter	Up to 48 weeks
Incidence of cardiovascular (CV) mortality	Up to 48 weeks
Incidence of nonvasovagal syncope and seizures	Up to 48 weeks
TEAEs leading to discontinuation from study intervention	Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)	Up to 48 weeks
Severity of TEAEs	Up to 48 weeks

Trial Locations

Locations (89)

Local Institution - 0094; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0087; 🇺🇸 West Hollywood, California, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0091; 🇺🇸 Honolulu, Hawaii, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Luzerner Kantonsspital (LUKS); 🇨🇭 Luzern, Luzern (de), Switzerland

Istituto Cardiocentro Ticino; 🇨🇭 Lugano, Ticino (it), Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

Local Institution - 0093; 🇺🇸 Boston, Massachusetts, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Local Institution - 0035; 🇺🇸 Murray, Utah, United States

Local Institution - 0075; 🇦🇷 Caba, Buenos Aires, Argentina

Local Institution - 0090; 🇺🇸 Cleveland, Ohio, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0076; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0079; 🇦🇷 Pilar, Buenos Aires, Argentina

Local Institution - 0077; 🇦🇷 Ciudad De Cordoba, Cordoba, Argentina

Local Institution - 0074; 🇦🇷 Rosario, Santa FE, Argentina

Local Institution - 0080; 🇦🇷 Buenos Aires, Argentina

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Local Institution - 0082; 🇦🇺 Darlinghurst, New South Wales, Australia

Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

Local Institution - 0022; 🇦🇺 Herston, Queensland, Australia

Local Institution - 0057; 🇦🇹 Klagenfurt am Wörthersee, Kärnten, Austria

Local Institution - 0032; 🇦🇹 Braunau am Inn, Upper Austria, Austria

Local Institution - 0028; 🇦🇹 Graz, Austria

Local Institution - 0088; 🇦🇹 Wien, Austria

Local Institution - 0007; 🇦🇹 Wien, Austria

Local Institution - 0084; 🇧🇪 Anderlecht, Brussels, Belgium

Local Institution - 0070; 🇧🇪 Bruxelles, Brussels, Belgium

Local Institution - 0069; 🇧🇪 Jette, Brussels, Belgium

Local Institution - 0092; 🇧🇪 Genk, Limburg, Belgium

Local Institution - 0083; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Local Institution - 0071; 🇧🇪 Roeselare, West-Vlaanderen, Belgium

Local Institution - 0004; 🇨🇦 Calgary, Alberta, Canada

Local Institution - 0001; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0068; 🇨🇦 Quebec, Canada

Local Institution - 0016; 🇨🇿 Broumov, Královéhradecký Kraj, Czechia

Local Institution - 0053; 🇨🇿 Trinec, Moravskoslezský Kraj, Czechia

Local Institution - 0050; 🇨🇿 Prague, Praha, Hlavní Mesto, Czechia

Local Institution - 0011; 🇨🇿 Praha 2, Praha, Hlavní Mesto, Czechia

Local Institution - 0052; 🇨🇿 Brno, Czechia

Local Institution - 0073; 🇫🇮 Helsinki, Etelä-Suomen Lääni, Finland

Local Institution - 0072; 🇫🇮 Turku, Länsi-Suomen Lääni, Finland

Local Institution - 0031; 🇫🇷 Grenoble, France

Local Institution - 0014; 🇫🇷 Paris, France

Local Institution - 0026; 🇫🇷 Pessac, France

Local Institution - 0002; 🇫🇷 Rennes, France

Local Institution - 0047; 🇩🇪 Giessen, Hessen, Germany

Local Institution - 0034; 🇩🇪 Göttingen, Niedersachsen, Germany

Local Institution - 0040; 🇩🇪 Bad Oeynhausen, Nordrhein-Westfalen, Germany

Local Institution - 0023; 🇩🇪 Berlin, Germany

Local Institution - 0009; 🇬🇷 Athina, Attiki, 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, Greece

Local Institution - 0042; 🇭🇺 Pécs, Baranya, Hungary

Local Institution - 0054; 🇭🇺 Szeged, Csongrád, Hungary

Local Institution - 0020; 🇭🇺 Balatonfüred, Veszprém, Hungary

Local Institution - 0019; 🇭🇺 Budapest, Hungary

Local Institution - 0013; 🇭🇺 Budapest, Hungary

Local Institution - 0041; 🇭🇺 Budapest, Hungary

Local Institution - 0063; 🇭🇺 Budapest, Hungary

Local Institution - 0038; 🇮🇹 Milano, Lombardia, Italy

Local Institution - 0060; 🇮🇹 Milano, Lombardia, Italy

Local Institution - 0056; 🇮🇹 Pavia, Lombardia, Italy

Local Institution - 0048; 🇮🇹 Firenze, Toscana, Italy

Local Institution - 0062; 🇮🇹 Pisa, Toscana, Italy

Local Institution - 0051; 🇮🇹 Arezzo, Italy

Local Institution - 0018; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0044; 🇵🇱 Katowice, Slaskie, Poland

Local Institution - 0049; 🇵🇱 Zabrze, Slaskie, Poland

Local Institution - 0064; 🇵🇱 Bialystok, Poland

Local Institution - 0012; 🇵🇱 Lódz, Poland

Local Institution - 0043; 🇪🇸 Palma de Mallorca, Baleares, Spain

Local Institution - 0046; 🇪🇸 Malaga, Málaga, Spain

Local Institution - 0030; 🇪🇸 Barcelona, Spain

Local Institution - 0089; 🇪🇸 Madrid, Spain

Local Institution - 0081; 🇪🇸 Madrid, Spain

Local Institution - 0045; 🇪🇸 Salamanca, Spain

Local Institution - 0039; 🇪🇸 Sevilla, Spain

Local Institution - 0055; 🇨🇭 Lugano, Ticino (it), Switzerland

Local Institution - 0036; 🇨🇭 Bern, Switzerland

Universitätsspital Zürich; 🇨🇭 Zürich (de), Switzerland

Local Institution - 0027; 🇬🇧 Belfast, Antrim, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, Yorkshire, United Kingdom

Local Institution - 0010; 🇬🇧 London, United Kingdom