A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Launched by BRISTOL-MYERS SQUIBB · Oct 27, 2023
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called mavacamten on the heart's structure in adults who have a condition known as symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This condition causes the heart muscle to thicken, which can lead to problems with blood flow. The researchers will use a special type of imaging called cardiac magnetic resonance imaging (CMR) to see how mavacamten affects the heart over time. The trial is currently looking for participants aged 65 to 74 who experience moderate symptoms (New York Heart Association Functional Class II or III) related to their heart condition.
To be eligible for this study, participants must have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy along with specific heart function measurements, such as having a certain level of pressure in the heart during exercise. However, individuals with certain other heart conditions, a history of serious heart events, or devices like pacemakers that interfere with the imaging cannot participate. Those who join the study can expect to undergo regular imaging tests to monitor their heart's structure while taking the medication. This trial aims to provide valuable information about how mavacamten may help improve the heart condition in those affected.
Gender
ALL
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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Atlanta, Georgia, United States
Houston, Texas, United States
Montreal, Quebec, Canada
Melbourne, Victoria, Australia
Camperdown, New South Wales, Australia
Chermside, Queensland, Australia
Murray, Utah, United States
Luzern, , Switzerland
Geneva, , Switzerland
Pilar, Buenos Aires, Argentina
Pittsburgh, Pennsylvania, United States
Lugano, , Switzerland
Leeds, Yorkshire, United Kingdom
Pittsburgh, Pennsylvania, United States
Camperdown, New South Wales, Australia
West Hollywood, California, United States
Sevilla, , Spain
Malaga, , Spain
Cleveland, Ohio, United States
Honolulu, Hawaii, United States
Cleveland, Ohio, United States
Graz, , Austria
Wien, , Austria
Genk, Limburg, Belgium
Madrid, , Spain
Bern, , Switzerland
Darlinghurst, New South Wales, Australia
Roeselare, West Vlaanderen, Belgium
Calgary, Alberta, Canada
Prague, Praha, Hlavní Mesto, Czechia
Geneva, , Switzerland
Ciudad De Cordoba, Cordoba, Argentina
Broumov, Královéhradecký Kraj, Czechia
Praha 2, Praha, Hlavní Mesto, Czechia
Balatonfüred, Veszprém, Hungary
Budapest, , Hungary
Budapest, , Hungary
Warszawa, Mazowieckie, Poland
Lódz, , Poland
Palma De Mallorca, Baleares, Spain
Lugano, Ticino (It), Switzerland
Luzern, , Switzerland
Braunau Am Inn, Upper Austria, Austria
Gießen, Hessen, Germany
Göttingen, Niedersachsen, Germany
Berlin, , Germany
Quebec, , Canada
Pessac, , France
Grenoble, , France
Budapest, , Hungary
Pécs, , Hungary
Warszawa, Mazowieckie, Poland
Katowice, Slaskie, Poland
Zabrze, Slaskie, Poland
Lugano, Ticino (It), Switzerland
Boston, Massachusetts, United States
Honolulu, Hawaii, United States
Klagenfurt, , Austria
Wien, , Austria
Anderlecht, Brussels, Belgium
Bruxelles, Brussels, Belgium
Jette, Brussels, Belgium
Leuven, Vlaams Brabant, Belgium
Trinec, Moravskoslezský Kraj, Czechia
Brno, , Czechia
Helsinki, Etelä Suomen Lääni, Finland
Turku, Länsi Suomen Lääni, Finland
Paris, , France
Rennes, , France
Giessen, Hessen, Germany
Bad Oeynhausen, Nordrhein Westfalen, Germany
Athina, Attiki, Greece
Chaidari, Athens, Attiki, Greece
Athens, , Greece
Heraklion, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Pécs, Baranya, Hungary
Szeged, Csongrád, Hungary
Budapest, , Hungary
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Firenze, Toscana, Italy
Massa, Toscana, Italy
Arezzo, , Italy
Pavia, , Italy
Malaga, Málaga, Spain
Barcelona, , Spain
Madrid, , Spain
Salamanca, , Spain
Herston, Queensland, Australia
Klagenfurt Am Wörthersee, Kärnten, Austria
Pavia, Lombardia, Italy
London, , United Kingdom
Houston, Texas, United States
Murray, Utah, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Melbourne, Victoria, Australia
West Hollywood, California, United States
Pittsburgh, Pennsylvania, United States
Caba, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Montreal, Quebec, Canada
Quebec, , Canada
Athina, Attiki, Greece
Thessaloniki, , Greece
Pisa, Toscana, Italy
Bialystok, , Poland
Genève, Genève (Fr), Switzerland
Zürich (De), , Switzerland
Belfast, Antrim, United Kingdom
Leeds, Yorkshire, United Kingdom
Luzern, Luzern (De), Switzerland
Zürich (De), , Switzerland
Lugano, Ticino (It), Switzerland
Luzern, Luzern (De), Switzerland
Lugano, Ticino (It), Switzerland
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Los Angeles, California, United States
Córdoba, Cordoba, Argentina
Rosario, Santa Fe, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Klagenfurt Am Wörthersee, , Austria
Broumov, , Czechia
Trinec, , Czechia
Prague, , Czechia
Praha 2, , Czechia
Helsinki, , Finland
Turku, , Finland
Szeged, , Hungary
Balatonfüred, , Hungary
Lugano, , Switzerland
West Hollywood, California, United States
Leeds, Yorkshire, United Kingdom
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported