Cardiomyopathy, HypertrophicPhase 4MEMENTONCT06112743
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 4 study testing Mavacamten in people with Cardiomyopathy, Hypertrophic, run by Bristol-Myers Squibb at 23 sites in 6 countries.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- What is being tested?
- Mavacamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 24 Jan 2024to 10 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States7 sites
Local Institution - 0003
Atlanta, Georgia, 30309
Local Institution - 0093
Boston, Massachusetts, 02114
Local Institution - 0090
Cleveland, Ohio, 44106
Local Institution - 0017
Houston, Texas, 77030
Local Institution - 0035
Murray, Utah, 84107-5701
Local Institution - 0086
Pittsburgh, Pennsylvania, 15212-4756
Local Institution - 0087
West Hollywood, California, 90048-1804
Argentina6 sites
Local Institution - 0080
Buenos Aires, 1199
Local Institution - 0076
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1093
Local Institution - 0075
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1428ART
Local Institution - 0077
Córdoba, Córdoba Province, X5021FPQ
Local Institution - 0079
Pilar, Buenos Aires, B1629ODT
Local Institution - 0074
Rosario, Santa Fe Province, S2000GAP
Switzerland4 sites
Local Institution - 0061
Geneva, 1205
Local Institution - 0058
Lucerne, Luzern (de), 6000
Local Institution - 0029
Lugano, Ticino (it), 6900
Local Institution - 0024
Zürich (de), 8091
Australia3 sites
Local Institution - 0015
Camperdown, New South Wales, 2050
Local Institution - 0085
Chermside, Queensland, 4032
Local Institution - 0005
Melbourne, Victoria, 3004
Canada2 sites
Local Institution - 0001
Montreal, Quebec, H1T 1C8
Local Institution - 0068
Québec, Quebec, G1V 4G5
United Kingdom1 site
Local Institution - 0025
Leeds, Yorkshire, LS1 3EX
About this study
Official title: MEMENTO - A Phase 4, Single-arm, Open-label 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)
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].
- Conditions
- Cardiomyopathy, Hypertrophic
- Being tested
- Mavacamten
- Keywords
- BMS-986427, MYK-461, Mavacamten, Obstructive Hypertrophic Cardiomyopathy (oHCM), Camyzos, Cardiac Magnetic Resonance Imaging (CMR)
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten | Experimental | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
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 maximum LAVI from baseline
- A decrease of at least 5 g/m2 in LVMI from baseline
Measured: At week 48
Secondary outcomes (17)
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
Measured: At week 48
Change from baseline in maximum left atrial volume index (LAVI) at Week 48
Measured: At week 48
Change from baseline in left ventricular mass index (LVMI) at Week 48
Measured: At week 48
Incidence of major adverse cardiac events (MACE)
Measured: Up to 48 weeks
Incidence of MACE-expanded events
Measured: Up to 48 weeks
All-cause mortality
Measured: Up to 48 weeks
Incidence of heart failure (HF) events
Measured: Up to 48 weeks
Incidence of HF events with systolic dysfunction
Measured: Up to 48 weeks
Incidence of atrial fibrillation (AF)/atrial flutter
Measured: Up to 48 weeks
Incidence of cardiovascular (CV) mortality
Measured: Up to 48 weeks
Incidence of ventricular tachyarrhythmias
Measured: Up to 48 weeks
Incidence of nonvasovagal syncope and seizures
Measured: Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)
Measured: Up to 48 weeks
Severity of TEAEs
Measured: Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)
Measured: Up to 48 weeks
TEAEs leading to discontinuation from study intervention
Measured: Up to 48 weeks
TEAEs leading to laboratory abnormalities
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start24 Jan 2024
- Primary completion16 Jul 2026
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112743
- Sponsor's protocol ID
- CV027-1088
- Acronym
- MEMENTO
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEMENTO - A Phase 4, Single-arm, Open-label 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)
- ClinicalTrials.gov ID
- NCT06112743
- Acronym / sponsor ID
- MEMENTO / CV027-1088
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- BMS-986427, MYK-461, Mavacamten, Obstructive Hypertrophic Cardiomyopathy (oHCM), Camyzos, Cardiac Magnetic Resonance Imaging (CMR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavacamten | Experimental | Drug: Mavacamten |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MavacamtenSpecified dose on specified days | Drug | Mavacamten |
Primary outcome
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
Time frame: At week 48
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 maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline
17 secondary outcomes
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
Time frame: At week 48
Change from baseline in maximum left atrial volume index (LAVI) at Week 48
Time frame: At week 48
Change from baseline in left ventricular mass index (LVMI) at Week 48
Time frame: At week 48
Incidence of major adverse cardiac events (MACE)
Time frame: Up to 48 weeks
Incidence of MACE-expanded events
Time frame: Up to 48 weeks
All-cause mortality
Time frame: Up to 48 weeks
Incidence of heart failure (HF) events
Time frame: Up to 48 weeks
Incidence of HF events with systolic dysfunction
Time frame: Up to 48 weeks
Incidence of atrial fibrillation (AF)/atrial flutter
Time frame: Up to 48 weeks
Incidence of cardiovascular (CV) mortality
Time frame: Up to 48 weeks
Incidence of ventricular tachyarrhythmias
Time frame: Up to 48 weeks
Incidence of nonvasovagal syncope and seizures
Time frame: Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 48 weeks
Severity of TEAEs
Time frame: Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)
Time frame: Up to 48 weeks
TEAEs leading to discontinuation from study intervention
Time frame: Up to 48 weeks
TEAEs leading to laboratory abnormalities
Time frame: Up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mavacamten in people with Cardiomyopathy, Hypertrophic, run by Bristol-Myers Squibb at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Argentina, Switzerland, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48 (time frame: At week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.