Imaging Histone Deacetylase in the Heart
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 11C-Martinostat, PET-MRI.
- Who it may be relevant to
- Registry conditions: Heart Failure With Normal Ejection Fraction, Left Ventricular Hypertrophy, Aortic Valve Stenosis, Diabetes. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Imaging of Histone Deacetylase in the Heart
Overview
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.
Detailed description
Histone deacetylases (HDACs), a class of epigenetic enzymes, play an important role in the pathophysiology of heart failure, including development of left ventricular hypertrophy and myocardial fibrosis. Preclinical data demonstrate the importance of HDAC inhibition in attenuating these pathological processes and maintaining the integrity of the myocardium. However, the role of HDACs in the human heart, and the utility of HDAC inhibition remains unknown. Therefore, a noninvasive method to detect HDAC activity in the human heart in healthy individuals and patients with heart disease may be of major medical and public health value to help determine prognosis, direct therapy, and guide the development of novel therapies for heart failure. The investigators have recently developed a novel radiotracer, 11C-Martinostat, which binds with high affinity to class I HDACs. The objective of this protocol is to assess the utility of 11C-Martinostat PET-MR to detect HDAC expression in the hearts of healthy individuals and patients with severe aortic stenosis or diabetes.
Interventions
- Drug 11C-Martinostat
Imaging probe for evaluating the activity of histone deacetylase in the heart - Device PET-MRI
Siemens PET-MR Scanner (Biograph MMR)
Primary outcome measures
- 11C-Martinostat Binding [Time frame: 10-60 minutes post-injection]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT03549559 · 1R01HL141563