Imaging Histone Deacetylase in the Heart
Imaging of Histone Deacetylase in the Heart
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedDecember 22, 2025
December 1, 2025
7.5 years
May 25, 2018
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
11C-Martinostat Binding
Comparison of regional HDAC activity as measured by standard uptake value ratio (SUVR) of 11C-Martinostat between patient subjects with aortic stenosis or diabetes and healthy volunteers
10-60 minutes post-injection
Study Arms (3)
Healthy Subjects
ACTIVE COMPARATORHealthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Diabetes Patient Subjects
ACTIVE COMPARATORPatient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Aortic Stenosis Patient Subjects
EXPERIMENTALPatient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement.
Interventions
Imaging probe for evaluating the activity of histone deacetylase in the heart
Siemens PET-MR Scanner (Biograph MMR)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known contraindication to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 8, 2018
Study Start
September 7, 2018
Primary Completion
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12