Aortic Valve Stenosis Clinical Trials

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Imaging of Histone Deacetylase in the Heart

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
David E Sosnovik, MD
dsosnovik@mgh.harvard.edu
617-724-3407
Backup
Anne L Philip, MPH
alphilip@mgh.harvard.edu
617-726-0431
Time Frame
Start Date: 2018-09-07
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 96
Treatments
Active_comparator: Healthy Subjects
Healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Active_comparator: Diabetes Patient Subjects
Patient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Experimental: Aortic Stenosis Patient Subjects
Patient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov