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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06112743
Registration number
NCT06112743
Ethics application status
Date submitted
27/10/2023
Date registered
1/11/2023
Date last updated
13/05/2024
Titles & IDs
Public title
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
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Scientific title
MEMENTO - A Phase 3b/4, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)
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Secondary ID [1]
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2022-502316-36
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Secondary ID [2]
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CV027-1088
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Universal Trial Number (UTN)
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Trial acronym
MEMENTO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy, Hypertrophic
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
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Assessment method [1]
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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 LAVI from baseline
A decrease of at least 5 g/m2 in LVMI from baseline
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Timepoint [1]
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At week 48
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Secondary outcome [1]
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Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
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Assessment method [1]
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Timepoint [1]
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At week 48
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Secondary outcome [2]
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Change from baseline in left atrial volume index (LAVI) at Week 48
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Assessment method [2]
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Timepoint [2]
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At week 48
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Secondary outcome [3]
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Change from baseline in left ventricular mass index (LVMI) at Week 48
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Assessment method [3]
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Timepoint [3]
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At week 48
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Secondary outcome [4]
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Incidence of major adverse cardiac events (MACE)
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Assessment method [4]
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Timepoint [4]
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Up to 48 weeks
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Secondary outcome [5]
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Incidence of MACE-expanded events
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Assessment method [5]
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Timepoint [5]
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Up to 48 weeks
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Secondary outcome [6]
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All-cause mortality
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Assessment method [6]
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Timepoint [6]
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Up to 48 weeks
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Secondary outcome [7]
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Incidence of heart failure (HF) events
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Assessment method [7]
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Timepoint [7]
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Up to 48 weeks
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Secondary outcome [8]
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Incidence of atrial fibrillation (AF)/atrial flutter
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Assessment method [8]
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Timepoint [8]
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Up to 48 weeks
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Secondary outcome [9]
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Incidence of resuscitated cardiac arrest
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Assessment method [9]
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Timepoint [9]
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Up to 48 weeks
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Secondary outcome [10]
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Incidence of ventricular tachyarrhythmias
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Assessment method [10]
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Timepoint [10]
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Up to 48 weeks
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Secondary outcome [11]
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Incidence of nonvasovagal syncope and seizures
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Assessment method [11]
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Timepoint [11]
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Up to 48 weeks
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Secondary outcome [12]
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Incidence of treatment emergent adverse events (TEAEs)
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Assessment method [12]
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Timepoint [12]
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Up to 48 weeks
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Secondary outcome [13]
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Severity of TEAEs
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Assessment method [13]
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Timepoint [13]
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Up to 48 weeks
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Secondary outcome [14]
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Incidence of treatment emergent serious adverse events (SAEs)
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Assessment method [14]
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Timepoint [14]
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Up to 48 weeks
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Secondary outcome [15]
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Incidence of treatment emergent laboratory abnormalities
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Assessment method [15]
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Timepoint [15]
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Up to 48 weeks
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Secondary outcome [16]
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Incidence of adverse events (AEs)
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Assessment method [16]
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Timepoint [16]
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Up to 48 weeks
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Secondary outcome [17]
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Incidence of serious adverse events (SAEs)
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Assessment method [17]
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Timepoint [17]
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Up to 48 weeks
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Secondary outcome [18]
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Incidence of AEs leading to discontinuation from study intervention
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Assessment method [18]
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Timepoint [18]
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Up to 48 weeks
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Eligibility
Key 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 mm Hg and = 50 mm Hg after
Valsalva or after exercise
- Left ventricular ejection fraction (LVEF) = 55% at rest
- New York Heart Association (NYHA) functional class II or III symptoms
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
Note: Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/10/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Local Institution - 0082 - Darlinghurst
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Recruitment hospital [2]
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Local Institution - 0022 - Herston
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Georgia
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Hawaii
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Massachusetts
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Ohio
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Utah
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Argentina
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Cordoba
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Austria
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Kärnten
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Austria
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Upper Austria
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Austria
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Graz
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Austria
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Wien
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Brussels
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Belgium
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Limburg
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Belgium
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Vlaams Brabant
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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].
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06112743
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06112743
Download to PDF