Recruiting

11C-Martinostat

Sponsor:

Massachusetts General Hospital

Code:

NCT03549559

Conditions

Heart Failure With Normal Ejection Fraction

Left Ventricular Hypertrophy

Aortic Valve Stenosis

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

11C-Martinostat

PET-MRI

Study Details

Brief summary:

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.

Conditions

Heart Failure With Normal Ejection Fraction

Left Ventricular Hypertrophy

Aortic Valve Stenosis

Diabetes

Study ID

NCT03549559

Start date

Sep 7, 2018

Status verified date

Dec, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Group 1: Healthy Volunteers (n = 30)

  • Healthy adults with no known history of medical disease
  • Age 18-85 years
  • No history cardiovascular disease
  • Ability to provide informed consent

Group 2: Patients with Diabetes (n = 16)

  • Age 18-85 years
  • Diagnosis of diabetes
  • Echocardiogram within last 12 months showing no evidence of left ventricular hypertrophy or hemodynamic findings consistent with heart failure with preserved ejection fraction
  • Ability to provide informed consent

Group 3: Patients with Aortic Stenosis (n = 50)

  • Age 18-85 years
  • Echocardiogram or cardiac MRI scan within last 12 months documenting left ventricular hypertrophy and degenerative calcific aortic stenosis
  • Ability to provide informed consent

Exclusion Criteria:

  • Known contraindication to MRI

Study Design

Enrollment

96 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

11C-Martinostat

Imaging probe for evaluating the activity of histone deacetylase in the heart

PET-MRI

Siemens PET-MR Scanner (Biograph MMR)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David E Sosnovik, MD

617-724-3407dsosnovik@mgh.harvard.edu

Anne L Philip, MPH

617-726-0431alphilip@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-22.