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RecruitingNCT06023186MavaPETUpdated Nov 6, 2024

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

An observational study in Obstructive Hypertrophic Cardiomyopathy, sponsored by Michael Ayers. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by Michael Ayers · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 20 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

This is the only study on the registry with Michael Ayers as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Willingness and ability to provide written informed consent
  2. Willingness and ability to comply with scheduled visits and study procedures
  3. Male or female, aged 18-85 years
  4. 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.
  5. Has been prescribed mavacamten consistent with US Prescribing Information
  6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
  7. For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Known hypersensitivity to components of mavacamten or regadenoson
  3. Prior treatment with mavacamten or aficamten
  1. 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician.

    Drug: mavacamten

Interventions

  • Drugmavacamten

    Study participants will receive mavacamten under the standard of care

    Also known as: Camzyos

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    • Caroline L Flournoy · Contact · clf4w@uvahealth.org · 434-924-6104
    • Michael Ayers, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No data on individual participants will be shared outside the University of Virginia.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06023186
Lead sponsor
Michael Ayers
Collaborators
Bristol-Myers Squibb
Responsible party
Michael Ayers (Assistant Professor, University of Virginia) — Sponsor-investigator
First posted
Sep 5, 2023
Start date
Nov 3, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Nov 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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