Obstructive Hypertrophic Cardiomyopathy (oHCM)SPARC-HCMNCT07557498
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Mavacamten
- How many people
- 362 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2026to 17 Jun 2027
- Phase
- Observational
- 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
Study population: The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.
Who may be able to join
- Phase I: retrospective chart review
- For inclusion in the study, participants must meet ALL of the following criteria:
- Are an adult aged 18 or over at baseline
- Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM)
- Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024
- Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted)
- Are not enrolled in any interventional clinical trial at study baseline
- Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey
Who cannot join
- None with the proviso that all inclusion criteria are met.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United Kingdom1 site, 1 recruiting
- Recruiting
Adelphi Real World
Bollington, Macclesfield, SK10 5JB
USA Generic Country, Site 0001, 0000000000
About this study
Official title: Mavacamten Real-World OutcomeS and the Associated PAtient and Physician ExpeRienCe With Hypertrophic CardioMyopathy in the United States (US) Community
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice
- Being tested
- Mavacamten
- Keywords
- Obstructive Hypertrophic cardiomyopathy (oHCM)
- 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
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten Receives: Drug: Mavacamten | |
| Group 2 | Physicians treating patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant blood pressure (both systolic and diastolic)
Group 1 only
Measured: Baseline
Date of diagnosis of hypertrophic cardiomyopathy
Group 1 only
Measured: Baseline
Hypertrophic cardiomyopathy genetic testing results
Group 1 only
Measured: Baseline
Family history of hypertrophic cardiomyopathy
Group 1 only
Measured: Baseline
Family history of Sudden Cardiac Death (SCD)
Group 1 only
Measured: Baseline
Participant comorbidities (cardiovascular and non-cardiovascular )
Group 1 only
Measured: Baseline
Type of prior surgeries and procedures
Group 1 only. Prior surgeries and procedures include: Septal Reduction Therapy (SRT), surgeries (valve repair/placement, left atrial appendage ligation), placement of devices (Implantable Cardioverter Defibrillator (ICD), pacemaker and cardiac resynchronization therapy) or atrial fibrillation/flutter ablation
Measured: Baseline and up to week 24
Participant New York Heart Association (NYHA) class category
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Change in participant New York Heart Association (NYHA) class from baseline
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Duration of mavacamten treatment
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Number of mavacamten dose titrations
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Type of mavacamten dose tritration
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Clinical reason for mavacamten dose titration
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Clinical reason for mavacamten treatment discontinuation
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%,
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Clinical reason for temporary mavacamten treatment interuption
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Time to temporary mavacamten treatment interruption
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50%
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Time to mavacamten treatment resumption
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed
Group 1 only
Measured: Baseline, and at weeks 4, 8, 12, 24
Type of changes to hypertrophic cardiomyopathy (HCM) background therapy
Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration
Measured: At baseline, weeks 4, 8, 12, 24
Secondary outcomes (1)
Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews
Group 2 only
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start15 Jan 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 362 participants (estimated)
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
- NCT07557498
- Sponsor's protocol ID
- CV027-1164
- Acronym
- SPARC-HCM
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mavacamten Real-World OutcomeS and the Associated PAtient and Physician ExpeRienCe With Hypertrophic CardioMyopathy in the United States (US) Community
- ClinicalTrials.gov ID
- NCT07557498
- Acronym / sponsor ID
- SPARC-HCM / CV027-1164
- Keywords
- Obstructive Hypertrophic cardiomyopathy (oHCM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 29 Apr 2026 (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 understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: MavacamtenParticipants with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten |
| Group 2 | – | Drug: MavacamtenPhysicians treating patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.
Key inclusion criteria (8 listed)
- Phase I: retrospective chart review
- Are an adult aged 18 or over at baseline
- Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM)
- Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024
- Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted)
Key exclusion criteria (1 listed)
- None with the proviso that all inclusion criteria are met.
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 |
|---|---|---|
| MavacamtenAccording to the product label | Drug | Group 1, Group 2 |
Primary outcome
Participant blood pressure (both systolic and diastolic)
Time frame: Baseline
Group 1 only
Date of diagnosis of hypertrophic cardiomyopathy
Time frame: Baseline
Group 1 only
Hypertrophic cardiomyopathy genetic testing results
Time frame: Baseline
Group 1 only
Family history of hypertrophic cardiomyopathy
Time frame: Baseline
Group 1 only
Family history of Sudden Cardiac Death (SCD)
Time frame: Baseline
Group 1 only
Participant comorbidities (cardiovascular and non-cardiovascular )
Time frame: Baseline
Group 1 only
Type of prior surgeries and procedures
Time frame: Baseline and up to week 24
Group 1 only. Prior surgeries and procedures include: Septal Reduction Therapy (SRT), surgeries (valve repair/placement, left atrial appendage ligation), placement of devices (Implantable Cardioverter Defibrillator (ICD), pacemaker and cardiac resynchronization therapy) or atrial fibrillation/flutter ablation
Participant New York Heart Association (NYHA) class category
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Change in participant New York Heart Association (NYHA) class from baseline
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Duration of mavacamten treatment
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Number of mavacamten dose titrations
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of mavacamten dose tritration
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for mavacamten dose titration
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for mavacamten treatment discontinuation
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%,
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for temporary mavacamten treatment interuption
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time to temporary mavacamten treatment interruption
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50%
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time to mavacamten treatment resumption
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed
Time frame: Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of changes to hypertrophic cardiomyopathy (HCM) background therapy
Time frame: At baseline, weeks 4, 8, 12, 24
Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration
1 secondary outcome
Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews
Time frame: Up to week 24
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 29 Apr 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
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?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant blood pressure (both systolic and diastolic) (time frame: Baseline). The study lists 23 primary outcomes in all. 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 29 Apr 2026.