Obstructive Hypertrophic CardiomyopathyMavaPETNCT06023186
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
An observational study of Obstructive Hypertrophic Cardiomyopathy, run by Michael Ayers at 1 site in United States.
Trial summary
The goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- mavacamten
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 30 Sep 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically stable adult obstructive hypertrophic cardiomyopathy patients on background therapy who have been prescribed Camzyos (mavacamten) in accordance with the US Prescribing Information, but who have not yet started this medication.
Who may be able to join
- Willingness and ability to provide written informed consent
- Willingness and ability to comply with scheduled visits and study procedures
- Male or female, aged 18-85 years
- Diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading conditions (e.g., hypertension, valvular, congenital disease) or infiltrative cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mm is sufficient for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those who are genotype positive.
- Has been prescribed mavacamten consistent with US Prescribing Information
- Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
- For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.
Who cannot join
- Pregnancy or lactation
- Known hypersensitivity to components of mavacamten or regadenoson
- Prior treatment with mavacamten or aficamten
- 11. Over weight limit for imaging gantry. 12. To minimize the risk of participants undergoing PET/CT with inadequate image quality, participants with left ventricular systolic dysfunction or lung disease will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Caroline L Flournoy, 434-924-6104, clf4w@uvahealth.org
Michael Ayers, MD
About this study
Official title: Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
The goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. The main question it aims to answer is:
- Does mavacamten treatment improve blood flow in the heart muscle?
Participants will take mavacamten at the direction of their treating physician. Participants will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT) scans. The first scan will be completed before participants start taking mavacamten. The scan will be repeated after 12 months of mavacamten treatment.
Read the detailed description
This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of care for oHCM. We hypothesize that 12 months of mavacamten therapy will improve myocardial blood flows as assessed by PET/CT. The investigation will take place at a single site. Participants who consent will be prospectively enrolled once mavacamten therapy has been approved by their health insurance/payer. Enrolled participants will undergo myocardial PET/CT before starting mavacamten and after 12 months of therapy.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- 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
Also called Camzyos
Study participants will receive mavacamten under the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician. Receives: Drug: mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial perfusion reserve after 12 months of mavacamten treatment.
Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start3 Nov 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Ayers
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Michael Ayers, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023186
- Sponsor's protocol ID
- HSR220293
- Acronym
- MavaPET
- Status last verified
- Nov 2024
- First submitted
- 28 Aug 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No data on individual participants will be shared outside the University of Virginia.