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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

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
2021-005329-26
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 cardiac troponin-T (cTn-T) to Week 48
Timepoint [4] 0 0
Up to Week 48
Secondary outcome [5] 0 0
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48
Timepoint [5] 0 0
Up to Week 48
Secondary outcome [6] 0 0
Time to first major adverse cardiovascular events (MACE)-plus events
Timepoint [6] 0 0
Up to 120 Weeks

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
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2010 - Darlinghurst
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2170 - Sydney
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4032 - Chermside
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4064 - Milton
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5042 - Bedford Park
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6150 - Murdoch
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05582395