Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05582395




Registration number
NCT05582395
Ethics application status
Date submitted
14/09/2022
Date registered
17/10/2022
Date last updated
26/10/2024

Titles & IDs
Public title
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
Scientific title
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Secondary ID [1] 0 0
U1111-1269-8581
Secondary ID [2] 0 0
CV027-031
Universal Trial Number (UTN)
Trial acronym
ODYSSEY-HCM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy, Hypertrophic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mavacamten
Other interventions - Placebo

Experimental: Mavacamten -

Placebo comparator: Placebo -


Treatment: Drugs: Mavacamten
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48
Timepoint [1] 0 0
Up to Week 48
Primary outcome [2] 0 0
Change from baseline in peak oxygen consumption (pVO2) at Week 48
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [1] 0 0
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48
Timepoint [1] 0 0
Up to Week 48
Secondary outcome [2] 0 0
Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [3] 0 0
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48
Timepoint [3] 0 0
Up to Week 48
Secondary outcome [4] 0 0
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48
Timepoint [4] 0 0
Up to Week 48

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - 0063 - Concord
Recruitment hospital [2] 0 0
Local Institution - 0085 - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - 0369 - Sydney
Recruitment hospital [4] 0 0
Local Institution - 0080 - Chermside
Recruitment hospital [5] 0 0
Local Institution - 0078 - Milton
Recruitment hospital [6] 0 0
Local Institution - 0050 - Bedford Park
Recruitment hospital [7] 0 0
Local Institution - 0076 - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2170 - Sydney
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Austria
State/province [25] 0 0
Oberösterreich
Country [26] 0 0
Austria
State/province [26] 0 0
Tirol
Country [27] 0 0
Austria
State/province [27] 0 0
Upper Austria
Country [28] 0 0
Austria
State/province [28] 0 0
Graz
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussels
Country [32] 0 0
Belgium
State/province [32] 0 0
Limburg
Country [33] 0 0
Belgium
State/province [33] 0 0
Vlaams Brabant
Country [34] 0 0
Brazil
State/province [34] 0 0
Bahia
Country [35] 0 0
Brazil
State/province [35] 0 0
Distrito Federal
Country [36] 0 0
Brazil
State/province [36] 0 0
MG
Country [37] 0 0
Brazil
State/province [37] 0 0
RIO Grande DO SUL
Country [38] 0 0
Brazil
State/province [38] 0 0
SAO Paulo
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio De Janeiro
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio de Janeiro
Country [41] 0 0
Brazil
State/province [41] 0 0
Sao Paulo
Country [42] 0 0
Canada
State/province [42] 0 0
Alberta
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
China
State/province [46] 0 0
Beijing
Country [47] 0 0
China
State/province [47] 0 0
Chongqing
Country [48] 0 0
China
State/province [48] 0 0
Guangdong
Country [49] 0 0
China
State/province [49] 0 0
Henan
Country [50] 0 0
China
State/province [50] 0 0
Hubei
Country [51] 0 0
China
State/province [51] 0 0
Hunan
Country [52] 0 0
China
State/province [52] 0 0
Jiangsu
Country [53] 0 0
China
State/province [53] 0 0
Jiangxi
Country [54] 0 0
China
State/province [54] 0 0
Jilin
Country [55] 0 0
China
State/province [55] 0 0
Liaoning
Country [56] 0 0
China
State/province [56] 0 0
Shan1xi
Country [57] 0 0
China
State/province [57] 0 0
Shandong
Country [58] 0 0
China
State/province [58] 0 0
Shanghai
Country [59] 0 0
China
State/province [59] 0 0
Sichuan
Country [60] 0 0
China
State/province [60] 0 0
Zhejiang
Country [61] 0 0
China
State/province [61] 0 0
Tianjin
Country [62] 0 0
Czechia
State/province [62] 0 0
Královéhradecký Kraj
Country [63] 0 0
Czechia
State/province [63] 0 0
Praha, Hlavní Mesto
Country [64] 0 0
Czechia
State/province [64] 0 0
Brno
Country [65] 0 0
Denmark
State/province [65] 0 0
Nordjylland
Country [66] 0 0
Denmark
State/province [66] 0 0
Sønderjylland
Country [67] 0 0
Denmark
State/province [67] 0 0
Aarhus N
Country [68] 0 0
France
State/province [68] 0 0
Alpes-Maritimes
Country [69] 0 0
France
State/province [69] 0 0
Finistère
Country [70] 0 0
France
State/province [70] 0 0
Haute-Garonne
Country [71] 0 0
France
State/province [71] 0 0
Indre-et-Loire
Country [72] 0 0
France
State/province [72] 0 0
Isère
Country [73] 0 0
France
State/province [73] 0 0
Rhône
Country [74] 0 0
France
State/province [74] 0 0
Nantes Cedex 01
Country [75] 0 0
France
State/province [75] 0 0
Paris
Country [76] 0 0
France
State/province [76] 0 0
Pessac
Country [77] 0 0
France
State/province [77] 0 0
Rennes
Country [78] 0 0
Germany
State/province [78] 0 0
Baden-Württemberg
Country [79] 0 0
Germany
State/province [79] 0 0
Bayern
Country [80] 0 0
Germany
State/province [80] 0 0
Hessen
Country [81] 0 0
Germany
State/province [81] 0 0
Niedersachsen
Country [82] 0 0
Germany
State/province [82] 0 0
Nordrhein-Westfalen
Country [83] 0 0
Germany
State/province [83] 0 0
North Rhine Wesrphalia
Country [84] 0 0
Germany
State/province [84] 0 0
Rheinland-Pfalz
Country [85] 0 0
Germany
State/province [85] 0 0
Schleswig-Holstein
Country [86] 0 0
Germany
State/province [86] 0 0
Thüringen
Country [87] 0 0
Germany
State/province [87] 0 0
Berlin
Country [88] 0 0
Germany
State/province [88] 0 0
Freiburg
Country [89] 0 0
Germany
State/province [89] 0 0
Hamburg
Country [90] 0 0
Germany
State/province [90] 0 0
Heidelberg
Country [91] 0 0
Germany
State/province [91] 0 0
München
Country [92] 0 0
Germany
State/province [92] 0 0
Münster
Country [93] 0 0
Hungary
State/province [93] 0 0
Veszprém
Country [94] 0 0
Hungary
State/province [94] 0 0
Budapest
Country [95] 0 0
Hungary
State/province [95] 0 0
Szeged
Country [96] 0 0
India
State/province [96] 0 0
Gujarat
Country [97] 0 0
India
State/province [97] 0 0
Karnataka
Country [98] 0 0
India
State/province [98] 0 0
Kerala
Country [99] 0 0
India
State/province [99] 0 0
Chandigarh
Country [100] 0 0
India
State/province [100] 0 0
Gurgaon
Country [101] 0 0
Israel
State/province [101] 0 0
Tel-Aviv
Country [102] 0 0
Israel
State/province [102] 0 0
Yerushalayim
Country [103] 0 0
Israel
State/province [103] 0 0
Haifa
Country [104] 0 0
Israel
State/province [104] 0 0
Petah Tikva
Country [105] 0 0
Israel
State/province [105] 0 0
Ramat -Gan
Country [106] 0 0
Israel
State/province [106] 0 0
Rehovot
Country [107] 0 0
Israel
State/province [107] 0 0
Safed
Country [108] 0 0
Italy
State/province [108] 0 0
Lazio
Country [109] 0 0
Italy
State/province [109] 0 0
Toscana
Country [110] 0 0
Japan
State/province [110] 0 0
Ehime
Country [111] 0 0
Japan
State/province [111] 0 0
Hyogo
Country [112] 0 0
Japan
State/province [112] 0 0
Ishikawa
Country [113] 0 0
Japan
State/province [113] 0 0
Kanagawa
Country [114] 0 0
Japan
State/province [114] 0 0
Kochi
Country [115] 0 0
Japan
State/province [115] 0 0
MIE
Country [116] 0 0
Japan
State/province [116] 0 0
Miyagi
Country [117] 0 0
Japan
State/province [117] 0 0
Osaka
Country [118] 0 0
Japan
State/province [118] 0 0
Shizuoka
Country [119] 0 0
Japan
State/province [119] 0 0
Tokyo
Country [120] 0 0
Japan
State/province [120] 0 0
Fukuoka
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Incheon Gwang'yeogsi
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Seoul Teugbyeolsi
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Busan
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Daegu
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seongnam-si
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Seoul
Country [127] 0 0
Netherlands
State/province [127] 0 0
Gelderland
Country [128] 0 0
Netherlands
State/province [128] 0 0
Limburg
Country [129] 0 0
Netherlands
State/province [129] 0 0
Noord-Holland
Country [130] 0 0
Netherlands
State/province [130] 0 0
Zuid-Holland
Country [131] 0 0
Netherlands
State/province [131] 0 0
Utrecht
Country [132] 0 0
Norway
State/province [132] 0 0
Lørenskog
Country [133] 0 0
Norway
State/province [133] 0 0
Oslo
Country [134] 0 0
Norway
State/province [134] 0 0
Trondheim
Country [135] 0 0
Poland
State/province [135] 0 0
Dolnoslaskie
Country [136] 0 0
Poland
State/province [136] 0 0
Lodzkie
Country [137] 0 0
Poland
State/province [137] 0 0
Malopolskie
Country [138] 0 0
Poland
State/province [138] 0 0
Mazowieckie
Country [139] 0 0
Poland
State/province [139] 0 0
Podkarpackie
Country [140] 0 0
Poland
State/province [140] 0 0
Slaskie
Country [141] 0 0
Poland
State/province [141] 0 0
Bialystok
Country [142] 0 0
Poland
State/province [142] 0 0
Lódz
Country [143] 0 0
Portugal
State/province [143] 0 0
Braga
Country [144] 0 0
Portugal
State/province [144] 0 0
Porto
Country [145] 0 0
Portugal
State/province [145] 0 0
Almada
Country [146] 0 0
Portugal
State/province [146] 0 0
Leiria
Country [147] 0 0
Portugal
State/province [147] 0 0
Lisboa
Country [148] 0 0
Spain
State/province [148] 0 0
Baleares
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Murcia
Country [152] 0 0
Spain
State/province [152] 0 0
Málaga
Country [153] 0 0
Spain
State/province [153] 0 0
A Coruna
Country [154] 0 0
Spain
State/province [154] 0 0
Alicante
Country [155] 0 0
Spain
State/province [155] 0 0
Granada
Country [156] 0 0
Spain
State/province [156] 0 0
Salamanca
Country [157] 0 0
Spain
State/province [157] 0 0
Sevilla
Country [158] 0 0
Spain
State/province [158] 0 0
Valencia
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Greater London
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Lanarkshire
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Birmingham
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT05582395
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05582395