Obstructive Hypertrophic Cardiomyopathy (oHCM)NCT07107373
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
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 safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers 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
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2023to 31 Dec 2027
- Phase
- Observational
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 treatment between April 29th, 2022, and August 6th, 2024
Who may be able to join
- Age ≥ 18 years at the index date
- Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III
- ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting
Who cannot join
- Data collection as part of a clinical trial during the study period
- Participation in a myosin inhibitor clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco (UCSF)
San Francisco, California, 94118
About this study
Official title: MavAcamten Real World eVidEnce coLlaboration in HCM (MARVEL-HCM)
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
- Being tested
- Mavacamten
- 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 receiving treatment mavacamten | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
New York Heart Association (NYHA) functional class
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
Left ventricular outflow tract (LVOT) gradient and associated parameters
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
Left ventricular ejection fraction (LVEF) and associated parameters
Measured: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
Secondary outcomes (8)
Mavacamten dose at initiation
Measured: Day 1
Mavacamten dose change
Measured: Up to 72 weeks
Reason for mavacamten dose change
Measured: Up to 72 weeks
Reason for mavacamten permanent discontinuation
Measured: Up to 72 weeks
Reason for treatment interruption
Measured: Up to 72 weeks
Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies
Measured: Baseline
Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies
Measured: Up to 72 weeks
Other cardiovascular-related treatments prescribed
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start22 Dec 2023
- Primary completion26 Jul 2024
- Study completion31 Dec 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
- Retrospective
- Enrolment
- 150 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 SquibbBristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107373
- Sponsor's protocol ID
- CV027-1152
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No