A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Cardiomyopathy, Hypertrophic Clinical Trial

— ODYSSEY-HCM  

Official title:

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05582395
• Other study ID #: CV027-031
• Secondary ID: 2021-005329-26U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 14, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness = 15 millimeters (mm) (or = 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation.

• Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography).

• New York Heart Association (NYHA) Class II or III.

Exclusion Criteria

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.

• History of unexplained syncope within 6 months prior to screening.

• History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.

• 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
Australia	Local Institution - 0050	Bedford Park	South Australia
Australia	Local Institution - 0080	Chermside	Queensland
Australia	Local Institution - 0063	Concord	New South Wales
Australia	Local Institution - 0085	Darlinghurst	New South Wales
Australia	Local Institution - 0078	Milton	Queensland
Australia	Local Institution - 0076	Murdoch	Western Australia
Australia	Local Institution - 0369	Sydney	New South Wales
Austria	Local Institution - 0069	Braunau am Inn	Upper Austria
Austria	Local Institution - 0062	Graz
Austria	Local Institution - 0090	Innsbruck	Tirol
Austria	Local Institution - 0075	Linz	Oberösterreich
Austria	Local Institution - 0429	Wien
Belgium	Local Institution - 0034	Anderlecht	Brussels
Belgium	Local Institution - 0462	Edegem	Antwerpen
Belgium	Local Institution - 0476	Genk	Limburg
Belgium	Local Institution - 0319	Leuven	Vlaams Brabant
Brazil	Local Institution - 0488	Belo Horizonte	MG
Brazil	Local Institution - 0430	Bragança Paulista	SAO Paulo
Brazil	Local Institution - 0438	Brasília	Distrito Federal
Brazil	Local Institution - 0447	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0450	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0422	Ribeirão Preto	SAO Paulo
Brazil	Local Institution - 0446	Rio De Janeiro
Brazil	Local Institution - 0451	Rio de Janeiro
Brazil	Local Institution - 0413	Salvador	Bahia
Brazil	Local Institution - 0418	Sao Paulo
Brazil	Local Institution - 0412	São Paulo	SAO Paulo
Canada	Local Institution - 0381	Calgary	Alberta
Canada	Local Institution - 0414	Hamilton	Ontario
Canada	Local Institution - 0411	London	Ontario
Canada	Local Institution - 0093	Quebec
Canada	Local Institution - 0467	Vancouver	British Columbia
China	Local Institution - 0502	Beijing
China	Local Institution - 0534	Beijing	Beijing
China	Local Institution - 0535	Beijing	Beijing
China	Local Institution - 0544	Changchun	Jilin
China	Local Institution - 0548	Changsha	Hunan
China	Local Institution - 0533	Chengdu	Sichuan
China	Local Institution - 0503	Chongqing	Chongqing
China	Local Institution - 0541	Chongqing	Chongqing
China	Local Institution - 0540	Dalian	Liaoning
China	Local Institution - 0539	Guangzhou	Guangdong
China	Local Institution - 0543	Guangzhou	Guangdong
China	Local Institution - 0546	Jinan	Shandong
China	Local Institution - 0537	Shanghai	Shanghai
China	Local Institution - 0501	Shenyang	Liaoning
China	Local Institution - 0538	Shenyang	Liaoning
China	Local Institution - 0545	Suzhou	Jiangsu
China	Local Institution - 0536	Wenzhou	Zhejiang
China	Local Institution - 0542	Wuhan	Hubei
China	Local Institution - 0547	Xian	Shan1xi
Czechia	Local Institution - 0188	Brno
Czechia	Local Institution - 0086	Broumov	Královéhradecký Kraj
Czechia	Local Institution - 0033	Prague	Praha, Hlavní Mesto
Czechia	Local Institution - 0052	Praha 2	Praha, Hlavní Mesto
Denmark	Local Institution - 0428	Aabenraa	South Denmark
Denmark	Local Institution - 0045	Aalborg	Nordjylland
Denmark	Local Institution - 0019	Aarhus N
France	Local Institution - 0463	Brest	Finistère
France	Local Institution - 0067	Bron	Rhône
France	Local Institution - 0003	Chambray-lès-tours	Indre-et-Loire
France	Local Institution - 0489	La Tronche	Isère
France	Local Institution - 0009	Nantes Cedex 01
France	Local Institution - 0001	Nice	Alpes-Maritimes
France	Local Institution - 0004	Paris
France	Local Institution - 0006	Paris
France	Local Institution - 0053	Pessac
France	Local Institution - 0008	Rennes
France	Local Institution - 0005	Toulouse	Haute-Garonne
Germany	Local Institution - 0013	Bad Nauheim	Hessen
Germany	Local Institution - 0439	Bad Oeynhausen	Nordrhein-Westfalen
Germany	Local Institution - 0403	Berlin
Germany	Local Institution - 0174	Bielefeld	Nordrhein-Westfalen
Germany	Local Institution - 0071	Freiburg
Germany	Local Institution - 0496	Göttingen	Niedersachsen
Germany	Local Institution - 0032	Hamburg
Germany	Local Institution - 0448	Hannover	Niedersachsen
Germany	Local Institution - 0077	Heidelberg
Germany	Local Institution - 0016	Jena	Thüringen
Germany	Local Institution - 0273	Köln
Germany	Local Institution - 0066	Luebeck	Schleswig-Holstein
Germany	Local Institution - 0420	Mainz	Rheinland-Pfalz
Germany	Local Institution - 0022	München	Bayern
Germany	Local Institution - 0454	München
Germany	Local Institution - 0046	Münster
Germany	Local Institution - 0440	Regensburg	Bayern
Germany	Local Institution - 0404	Ulm	Baden-Württemberg
Hungary	Local Institution - 0423	Balatonfüred	Veszprém
Hungary	Local Institution - 0035	Budapest
Hungary	Local Institution - 0039	Budapest
Hungary	Local Institution - 0048	Budapest
Hungary	Local Institution - 0417	Szeged
India	Local Institution - 0482	Ahmedabad	Gujarat
India	Local Institution - 0480	Bengaluru	Karnataka
India	Local Institution - 0483	Chandigarh
India	Local Institution - 0330	Gurgaon
India	Local Institution - 0481	Kochi	Kerala
Israel	Local Institution - 0026	Ashkelon	Tel-Aviv
Israel	Local Institution - 0419	Haifa
Israel	Local Institution - 0025	Jerusalem	Yerushalayim
Israel	Local Institution - 0057	Jerusalem	Yerushalayim
Israel	Local Institution - 0427	Petah Tikva
Israel	Local Institution - 0074	Ramat Gan
Israel	Local Institution - 0054	Rehovot
Israel	Local Institution - 0253	Safed
Israel	Local Institution - 0037	Tel Aviv	Tel-Aviv
Italy	Local Institution - 0373	Firenze	Toscana
Italy	Local Institution - 0171	Massa	Toscana
Italy	Local Institution - 0028	Roma	Lazio
Japan	Local Institution - 0477	Bunkyo-ku	Tokyo
Japan	Local Institution - 0505	Chuo-Ku	Tokyo
Japan	Local Institution - 0521	Fukuoka
Japan	Local Institution - 0168	Hamamatsu-city	Shizuoka
Japan	Local Institution - 0208	Himeji-Shi	Hyogo
Japan	Local Institution - 0224	Itabashi-Ku	Tokyo
Japan	Local Institution - 0457	Kanazawa-shi	Ishikawa
Japan	Local Institution - 0466	Koto-Ku	Tokyo
Japan	Local Institution - 0119	Nankoku-shi	Kochi
Japan	Local Institution - 0452	Osaka-Shi	Osaka
Japan	Local Institution - 0456	Sendai	Miyagi
Japan	Local Institution - 0475	Shinjuku	Tokyo
Japan	Local Institution - 0314	Shinjuku-ku	Tokyo
Japan	Local Institution - 0315	Suita	Osaka
Japan	Local Institution - 0471	Takatsuki-Shi	Osaka
Japan	Local Institution - 0453	Tsu	MIE
Japan	Local Institution - 0370	Uwajima	Ehime
Japan	Local Institution - 0107	Yokohama	Kanagawa
Korea, Republic of	Local Institution - 0517	Busan
Korea, Republic of	Local Institution - 0516	Daegu
Korea, Republic of	Local Institution - 0518	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	Local Institution - 0508	Seongnam-si
Korea, Republic of	Local Institution - 0012	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Local Institution - 0049	Seoul
Korea, Republic of	Local Institution - 0055	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Local Institution - 0217	Seoul
Korea, Republic of	Local Institution - 0460	Seoul
Netherlands	Local Institution - 0197	Amsterdam Zuidoost	Noord-Holland
Netherlands	Local Institution - 0434	Maastricht	Limburg
Netherlands	Local Institution - 0442	Nijmegen	Gelderland
Netherlands	Local Institution - 0213	Rotterdam	Zuid-Holland
Netherlands	Local Institution - 0061	Utrecht
Norway	Local Institution - 0443	Lørenskog
Norway	Local Institution - 0441	Oslo
Norway	Local Institution - 0473	Trondheim
Poland	Local Institution - 0030	Bialystok
Poland	Local Institution - 0017	Katowice	Slaskie
Poland	Local Institution - 0042	Kraków	Malopolskie
Poland	Local Institution - 0059	Lodz	Lodzkie
Poland	Local Institution - 0416	Lódz
Poland	Local Institution - 0072	Rzeszów	Podkarpackie
Poland	Local Institution - 0203	Warszawa	Mazowieckie
Poland	Local Institution - 0338	Warszawa	Mazowieckie
Poland	Local Institution - 0038	Wroclaw	Dolnoslaskie
Poland	Local Institution - 0091	Wroclaw	Dolnoslaskie
Poland	Local Institution - 0415	Zabrze	Slaskie
Portugal	Local Institution - 0015	Almada
Portugal	Local Institution - 0044	Guimarães	Braga
Portugal	Local Institution - 0433	Leiria
Portugal	Local Institution - 0023	Lisboa
Portugal	Local Institution - 0024	Lisboa
Portugal	Local Institution - 0014	Vila Nova de Gaia	Porto
Spain	Local Institution - 0043	A Coruna
Spain	Local Institution - 0087	Alicante
Spain	Local Institution - 0018	Barcelona
Spain	Local Institution - 0056	Barcelona
Spain	Local Institution - 0237	El Palmar	Murcia
Spain	Local Institution - 0060	Granada
Spain	Local Institution - 0299	Hospitalet de Llobregat	Barcelona
Spain	Local Institution - 0421	Madrid
Spain	Local Institution - 0021	Majadahonda	Madrid
Spain	Local Institution - 0041	Malaga	Málaga
Spain	Local Institution - 0040	Palma de Mallorca	Baleares
Spain	Local Institution - 0031	Salamanca
Spain	Local Institution - 0051	Sevilla
Spain	Local Institution - 0027	Valencia
United Kingdom	Local Institution - 0407	Birmingham
United Kingdom	Local Institution - 0073	Glasgow	Lanarkshire
United Kingdom	Local Institution - 0445	London	Greater London
United Kingdom	Local Institution - 0472	London
United States	Local Institution - 0464	Ann Arbor	Michigan
United States	Local Institution - 0092	Atlanta	Georgia
United States	Local Institution - 0127	Baltimore	Maryland
United States	Local Institution - 0082	Birmingham	Alabama
United States	Local Institution - 0479	Boston	Massachusetts
United States	Local Institution - 0500	Boston	Massachusetts
United States	Local Institution - 0094	Charlotte	North Carolina
United States	Local Institution - 0478	Charlottesville	Virginia
United States	Local Institution - 0083	Cleveland	Ohio
United States	Local Institution - 0089	Dallas	Texas
United States	Local Institution - 0365	Dallas	Texas
United States	Local Institution - 0064	Detroit	Michigan
United States	Local Institution - 0065	Durham	North Carolina
United States	Local Institution - 0468	Gainesville	Florida
United States	Local Institution - 0207	Germantown	Tennessee
United States	Local Institution - 0455	Grand Rapids	Michigan
United States	Local Institution - 0047	Hershey	Pennsylvania
United States	Local Institution - 0424	Indianapolis	Indiana
United States	Local Institution - 0070	Iowa City	Iowa
United States	Local Institution - 0410	Kansas City	Kansas
United States	Local Institution - 0409	La Jolla	California
United States	Local Institution - 0444	Lancaster	Pennsylvania
United States	Local Institution - 0010	Los Angeles	California
United States	Local Institution - 0484	Louisville	Kentucky
United States	Local Institution - 0449	Manhasset	New York
United States	Local Institution - 0490	Morristown	New Jersey
United States	Local Institution - 0486	New York	New York
United States	Local Institution - 0435	Omaha	Nebraska
United States	Local Institution - 0079	Palo Alto	California
United States	Local Institution - 0263	Philadelphia	Pennsylvania
United States	Local Institution - 0458	Phoenix	Arizona
United States	Local Institution - 0081	Pittsburgh	Pennsylvania
United States	Local Institution - 0492	Plano	Texas
United States	Local Institution - 0095	Richmond	Virginia
United States	Local Institution - 0431	Rochester	Minnesota
United States	Local Institution - 0461	Saint Louis	Missouri
United States	Local Institution - 0402	Salt Lake City	Utah
United States	Local Institution - 0406	San Francisco	California
United States	Local Institution - 0007	Stony Brook	New York
United States	Local Institution - 0281	Tampa	Florida
United States	Local Institution - 0426	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48		Up to Week 48
Primary	Change from baseline in peak oxygen consumption (pVO2) at Week 48		Up to Week 48
Secondary	Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48		Up to Week 48
Secondary	Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48		Up to Week 48
Secondary	Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48		Up to Week 48
Secondary	Change from baseline in cardiac troponin-T (cTn-T) to Week 48		Up to Week 48
Secondary	Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48		Up to Week 48
Secondary	Time to first major adverse cardiovascular events (MACE)-plus events	Defined as any cardiovascular (CV) death, nonfatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, hospitalization for arrhythmias, or appropriate implantable cardioverter defibrillator (ICD) therapy	Up to 120 Weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting