Scanning the heart for a key enzyme (HDAC) using 11C‑Martinostat PET‑MR
Imaging of Histone Deacetylase in the Heart
This trial will test whether a PET‑MR scan with the tracer 11C‑Martinostat can detect HDAC enzyme activity in people with aortic stenosis, people with diabetes, and healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03549559 on ClinicalTrials.gov |
What this trial studies
This study uses a novel PET‑MR radiotracer, 11C‑Martinostat, that binds class I histone deacetylases (HDACs) to image enzyme expression in the human heart. Participants include healthy adults, people with diabetes without left ventricular hypertrophy, and patients with aortic stenosis and left ventricular hypertrophy. Each participant will undergo PET‑MR imaging to measure tracer uptake in the myocardium and compare HDAC signal across groups. The goal is to determine whether noninvasive imaging can reveal differences in cardiac HDAC activity that may relate to remodeling, fibrosis, or risk.
Who should consider this trial
Good fit: Ideal candidates are adults 18–85 who can undergo MRI and PET imaging and who fit one of the groups: healthy volunteers with no known disease, people with diabetes without LV hypertrophy, or patients with aortic stenosis and documented LV hypertrophy.
Not a fit: People with contraindications to MRI, those outside the 18–85 age range, or patients who do not meet the group-specific echocardiographic/MRI criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this imaging approach could allow noninvasive detection of HDAC activity in the heart to help guide prognosis, select therapies, and support development of new treatments for heart disease.
How similar studies have performed: Preclinical work supports HDAC’s role in cardiac remodeling and early human imaging with 11C‑Martinostat exists, but broader clinical utility of HDAC imaging remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: David E Sosnovik, MD
- Email: dsosnovik@mgh.harvard.edu
- Phone: 617-724-3407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.