NCT03549559

Imaging Histone Deacetylase in the Heart

Imaging of Histone Deacetylase in the Heart

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Heart Failure With Normal Ejection Fraction
• Left Ventricular Hypertrophy
• Aortic Valve Stenosis
• Diabetes

Interventions

Type	Name	Description
DRUG	11C-Martinostat	Imaging probe for evaluating the activity of histone deacetylase in the heart
DEVICE	PET-MRI	Siemens PET-MR Scanner (Biograph MMR)

Timeline

• Start date: 2018-09-07
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2018-06-08
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States