Obstructive Hypertrophic Cardiomyopathy (oHCM)NCT07168655
Mavacamten in Obstructive Hypertrophic Cardiomyopathy
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US 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
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 comprise of adult individuals diagnosed with Obstructive Hypertrophic cardiomyopathy (oHCM) that have been prescribed mavacamten at The Hospital of the University of Pennsylvania between April 1, 2022 and January 17, 2025
Who may be able to join
- Age ≥ 18 years at index date
- Prescription of mavacamten for the treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM)
- ≥ 4 weeks of follow-up after prescription of mavacamten
Who cannot join
- Data collection as part of a clinical trial during the study period
- Current participation in a myosin inhibitor clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Real-World Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten - a Single-Center Descriptive Study
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
- 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 |
|---|---|---|
| Participants prescribed mavacamten treatment | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant New York Heart Association (NYHA) functional class
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Left ventricular outflow tract (LVOT) gradient results at rest, Valsalva and post-exercise (if available)
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Left ventricular ejection fraction (LVEF) percentage
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Maximum left ventricular wall thickness
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant age
Measured: Baseline
Participant gender
Measured: Baseline
Participant race
Measured: Baseline
Participant ethnicity
Measured: Baseline
Participant insurance coverage
Measured: Baseline
Participant Body Mass Index
Measured: Baseline
Participant blood pressure
Measured: Baseline
Participant heart rate
Measured: Baseline
Participant genotype
Measured: Baseline
Participant family history
Measured: Baseline
Participant New York Functional Class classification
Measured: Baseline
Participant echocardiogram measurements
Measured: Baseline
Participant comorbidities
Measured: Baseline
Participant hypertrophic cardiomyopathy (HCM) treatment history
Measured: Baseline
Mavacamten index dose prescribed
Measured: Baseline
Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start21 Feb 2023
- Primary completion31 Mar 2023
- Study completion25 Mar 2025
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
- Retrospective
- Enrolment
- 163 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
- NCT07168655
- Sponsor's protocol ID
- CV027-1039
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten - a Single-Center Descriptive Study
- ClinicalTrials.gov ID
- NCT07168655
- Acronym / sponsor ID
- CV027-1039
- Keywords
- Obstructive Hypertrophic cardiomyopathy (oHCM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 11 Sep 2025 (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 real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants prescribed mavacamten treatment | – | Drug: Mavacamten |
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 comprise of adult individuals diagnosed with Obstructive Hypertrophic cardiomyopathy (oHCM) that have been prescribed mavacamten at The Hospital of the University of Pennsylvania between April 1, 2022 and January 17, 2025
Key inclusion criteria (3 listed)
- Age ≥ 18 years at index date
- Prescription of mavacamten for the treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM)
- ≥ 4 weeks of follow-up after prescription of mavacamten
Key exclusion criteria (2 listed)
- Data collection as part of a clinical trial during the study period
- Current participation in a myosin inhibitor clinical trial
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 | Participants prescribed mavacamten treatment |
Primary outcome
Participant New York Heart Association (NYHA) functional class
Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Left ventricular outflow tract (LVOT) gradient results at rest, Valsalva and post-exercise (if available)
Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Left ventricular ejection fraction (LVEF) percentage
Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant echocardiogram measurements: Maximum left ventricular wall thickness
Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant age
Time frame: Baseline
Participant gender
Time frame: Baseline
Participant race
Time frame: Baseline
Participant ethnicity
Time frame: Baseline
Participant insurance coverage
Time frame: Baseline
Participant Body Mass Index
Time frame: Baseline
Participant blood pressure
Time frame: Baseline
Participant heart rate
Time frame: Baseline
Participant genotype
Time frame: Baseline
Participant family history
Time frame: Baseline
Participant New York Functional Class classification
Time frame: Baseline
Participant echocardiogram measurements
Time frame: Baseline
Participant comorbidities
Time frame: Baseline
Participant hypertrophic cardiomyopathy (HCM) treatment history
Time frame: Baseline
Mavacamten index dose prescribed
Time frame: Baseline
Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- 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. This study is not recruiting at the moment.
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 States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Sep 2025. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant New York Heart Association (NYHA) functional class (time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks). The study lists 20 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 11 Sep 2025.