Heart Failure With Normal Ejection FractionNCT03549559
Imaging Histone Deacetylase in the Heart
A study testing 11C-Martinostat and PET-MRI in people with Heart Failure With Normal Ejection Fraction and Left Ventricular Hypertrophy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction, Left Ventricular Hypertrophy, Aortic Valve Stenosis
- What is being tested?
- 11C-Martinostat and PET-MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- Known contraindication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
David Sosnovik, MD
About this study
Official title: Imaging of Histone Deacetylase in the Heart
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.
Read the 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
- Being tested
- 11C-Martinostat, PET-MRI
- Medical subject headings
- Hypertrophy, Left Ventricular, Aortic Valve Stenosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-MartinostatDrug
Imaging probe for evaluating the activity of histone deacetylase in the heart
PET-MRIDevice
Siemens PET-MR Scanner (Biograph MMR)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI. Receives: Drug: 11C-Martinostat; Device: PET-MRI |
| Diabetes Patient Subjects | Active comparator | Patient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI. Receives: Drug: 11C-Martinostat; Device: PET-MRI |
| Aortic Stenosis Patient Subjects | Experimental | Patient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement. Receives: Drug: 11C-Martinostat; Device: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-Martinostat Binding
Comparison of regional HDAC activity as measured by standard uptake value ratio (SUVR) of 11C-Martinostat between patient subjects with aortic stenosis or diabetes and healthy volunteers
Measured: 10-60 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start7 Sep 2018
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Sosnovik, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549559
- Sponsor's protocol ID
- 1R01HL141563
- Status last verified
- Dec 2025
- First submitted
- 25 May 2018
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Histone Deacetylase in the Heart
- ClinicalTrials.gov ID
- NCT03549559
- Acronym / sponsor ID
- 1R01HL141563
- Conditions
- Heart Failure With Normal Ejection Fraction, Left Ventricular Hypertrophy, Aortic Valve Stenosis, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Drug: 11C-Martinostat, Device: PET-MRIHealthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI. |
| Diabetes Patient Subjects | Active comparator | Drug: 11C-Martinostat, Device: PET-MRIPatient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI. |
| Aortic Stenosis Patient Subjects | Experimental | Drug: 11C-Martinostat, Device: PET-MRIPatient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Known contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-MartinostatImaging probe for evaluating the activity of histone deacetylase in the heart | Drug | Aortic Stenosis Patient Subjects, Diabetes Patient Subjects, Healthy Subjects |
| PET-MRISiemens PET-MR Scanner (Biograph MMR) | Device | Aortic Stenosis Patient Subjects, Diabetes Patient Subjects, Healthy Subjects |
Primary outcome
11C-Martinostat Binding
Time frame: 10-60 minutes post-injection
Comparison of regional HDAC activity as measured by standard uptake value ratio (SUVR) of 11C-Martinostat between patient subjects with aortic stenosis or diabetes and healthy volunteers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Related trials for Heart Failure With Normal Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-Martinostat and PET-MRI in people with Heart Failure With Normal Ejection Fraction and Left Ventricular Hypertrophy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David E Sosnovik, MD (617-724-3407, dsosnovik@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11C-Martinostat Binding (time frame: 10-60 minutes post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.