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Imaging Histone Deacetylase in the Heart

NCT ID: NCT03549559

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2026-09-01

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Subjects

Healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.

Group Type ACTIVE_COMPARATOR

11C-Martinostat

Intervention Type DRUG

Imaging probe for evaluating the activity of histone deacetylase in the heart

PET-MRI

Intervention Type DEVICE

Siemens PET-MR Scanner (Biograph MMR)

Diabetes Patient Subjects

Patient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.

Group Type ACTIVE_COMPARATOR

11C-Martinostat

Intervention Type DRUG

Imaging probe for evaluating the activity of histone deacetylase in the heart

PET-MRI

Intervention Type DEVICE

Siemens PET-MR Scanner (Biograph MMR)

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.

Group Type EXPERIMENTAL

11C-Martinostat

Intervention Type DRUG

Imaging probe for evaluating the activity of histone deacetylase in the heart

PET-MRI

Intervention Type DEVICE

Siemens PET-MR Scanner (Biograph MMR)

Interventions

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11C-Martinostat

Imaging probe for evaluating the activity of histone deacetylase in the heart

Intervention Type DRUG

PET-MRI

Siemens PET-MR Scanner (Biograph MMR)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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David E Sosnovik

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David E Sosnovik, MD

Role: CONTACT

Phone: 617-724-3407

Email: [email protected]

Anne L Philip, MPH

Role: CONTACT

Phone: 617-726-0431

Email: [email protected]

Facility Contacts

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David Sosnovik, MD

Role: primary

Other Identifiers

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1R01HL141563

Identifier Type: NIH

Identifier Source: org_study_id

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