Imaging Histone Deacetylase in the Heart

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03549559
Status
Recruiting

Conditions

  • Aortic Valve Stenosis
  • Diabetes
  • Heart Failure With Normal Ejection Fraction
  • Left Ventricular Hypertrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 11C-Martinostat — DRUG
    Imaging probe for evaluating the activity of histone deacetylase in the heart
  • PET-MRI — DEVICE
    Siemens PET-MR Scanner (Biograph MMR)

Study Details

The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers.

Key Dates

Start date
Sep 7, 2018
Status verified
Dec 2025
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Subjects
    Healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
  • Active Comparator: Diabetes Patient Subjects
    Patient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
  • Experimental: Aortic Stenosis Patient Subjects
    Patient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement.

Primary Outcome Measure

11C-Martinostat Binding [ Time Frame: 10-60 minutes post-injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
David Sosnovik, MD

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