Actively Recruiting
Imaging of Histone Deacetylase in the Heart to Evaluate Enzyme Activity in Healthy Volunteers and Patients with Aortic Stenosis or Diabetes
Led by Massachusetts General Hospital · Updated on 2025-12-22
96
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 11C-Martinostat, a special imaging agent that targets histone deacetylases (HDACs), enzymes involved in heart conditions such as heart failure, left ventricular hypertrophy, and myocardial fibrosis. This study aims to understand HDAC activity in the hearts of healthy people and patients with severe aortic stenosis or diabetes. The goal is to help guide future heart failure treatments and improve prognosis using noninvasive imaging techniques. Participants include healthy volunteers, patients with diabetes, and patients with aortic stenosis. All receive an intravenous injection of 11C-Martinostat followed by simultaneous PET-MRI scans. Patients with aortic stenosis will have scans before and after transcatheter valve replacement. This helps assess HDAC expression and the impact of treatment. During the study, participants will undergo PET-MR imaging to measure 11C-Martinostat binding in the heart between 10 and 60 minutes after injection. Researchers will collect data from imaging scans to evaluate HDAC activity. The study includes adults aged 18 to 85 years without contraindications to MRI. Participation involves providing informed consent and completing imaging procedures under medical supervision.
CONDITIONS
Brief Title
Imaging Histone Deacetylase in the Heart
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 85 years with no known medical disease or cardiovascular history
- Adults aged 18 to 85 years with a diagnosis of diabetes and no evidence of left ventricular hypertrophy or heart failure by recent echocardiogram
- Adults aged 18 to 85 years with left ventricular hypertrophy and degenerative calcific aortic stenosis confirmed by recent echocardiogram or cardiac MRI
- Ability to provide informed consent
You will not qualify if you...
- Known contraindication to MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI to evaluate histone deacetylase activity in the heart.
1 visit (in-person)
Duration - Up to several months following valve replacement
Participants with aortic stenosis undergo repeat imaging after transcatheter valve replacement to assess changes in enzyme activity.
1 follow-up visit after valve replacement
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
David E Sosnovik, MD
A
Anne L Philip, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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