Heart Failure Preserved Ejection FractionPhase 4NCT07178145
Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction
A Phase 4 study testing GLP-1RA in people with Heart Failure Preserved Ejection Fraction and Epicardial Adipose Tissue, run by University of Virginia at 1 site in United States.
Trial summary
This study seeks to develop improved cardiac MRI (CMR) methods to quantify epicardial adipose tissue (EAT) composition and to demonstrate the advantages of EAT composition imaging (a) in advancing the understanding of the relationship between EAT and heart failure with preserved ejection fraction (HFpEF) and (b) for… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure Preserved Ejection Fraction, Epicardial Adipose Tissue
- What is being tested?
- GLP-1RA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to Dec 2029
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years - 90 years;
- LVEF ≥ 50%;
- ≥ 2 risk factors for HFpEF or symptoms that could be related to HFpEF (e.g., dyspnea, orthopnea, paroxysmal nocturnal dyspnea, lower extremity edema, pulmonary edema, etc);
- Not currently being treated with GLP-1RA therapy.
Who cannot join
- • Previously or currently reduced EF (<50%), including heart transplant; (2) Obstructive un-revascularized coronary disease by coronary CT or invasive coronary angiography;
- MI/PCI/CABG within the past 6 months;
- Untreated severe stenotic or regurgitant valvular disease;
- Infiltrative cardiomyopathy (Fabry/HCM/sarcoid/amyloid, etc);
- Myocarditis;
- Claustrophobia/inability to tolerate MRI;
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- Implants that are a contraindication for MRI or may negatively impact image quality (e.g. pacemakers and ICDs);
- Active systemic inflammatory disorder;
- Atrial fibrillation with rapid ventricular response at time of study; and
- Hemodynamic instability
- Pregnancy
- Prisoners
- Inability to provide informed consent
- Exclusion Criteria for Optional Cardiac Stress Imaging Procedure
- allergy to gadolinium-based contrast agents
- Acute kidney injury
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
- Hepatorenal syndrome
- History of liver transplant
- High-grade atrioventricular (AV) block
- Active asthma exacerbation
- Known allergy to vasodilator agents
- Recent seizure
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
University of Virginia
Charlottesville, Virginia, 22903
Shuo Wang, 434-982-1058, JR7CE@uvahealth.org
Amit Patel, MD
About this study
Official title: MRI of Epicardial Adipose Tissue Composition: Development of Methods and Application to Heart Failure With Preserved Ejection Fraction
This study seeks to develop improved cardiac MRI (CMR) methods to quantify epicardial adipose tissue (EAT) composition and to demonstrate the advantages of EAT composition imaging (a) in advancing the understanding of the relationship between EAT and heart failure with preserved ejection fraction (HFpEF) and (b) for understanding mechanisms of and guiding medical therapy in HFpEF. The investigators recently developed the first method for quantifying EAT FAC in human subjects, utilizing a rate-6 accelerated radial 2D multi-echo gradient-echo breathhold acquisition with a local low rank reconstruction. In this project the first specific aim is to develop a rapid free-breathing 3D EAT FAC MRI method that reduces motion-related artifacts, increases coverage, and facilitates higher spatial resolution and improved FAC reproducibility. The second specific aim is to show that EAT FAC is more strongly associated than EAT volume with cardiometabolic HFpEF. In this context, individuals with known or suspected HFpEF will undergo CMR, echocardiography, and other testing to (a) diagnose cardiometabolic HFpEF; (b) characterize features associated with the severity of HFpEF; and (c) assess EAT volume and FAC. The investigators will determine if EAT FAC is more strongly associated than EAT volume with HFpEF and with features associated with the severity of HFpEF. The third specific aim is to show, in the context of cardiometabolic HFpEF and pre-HFpEF, (a) that GLP-1 receptor agonism with semaglutide (SEMA) shifts the EAT FAC to a less proinflammatory profile and (b) that baseline EAT FAC is a stronger predictor than EAT volume of improved cardiovascular function due to SEMA. Cardiometabolic HFpEF and pre-HFpEF subjects will undergo echocardiography and CMR with EAT FAC at baseline and after 3 months to serve as a self-control. Subjects will then undergo repeat imaging 6 months after the initiation of SEMA. The change in FAC after treatment with SEMA will be compared to the change in FAC prior to SEMA. Data will be analyzed to show that SEMA changes EAT FAC, and that baseline EAT FAC is a stronger predictor than EAT volume of improvements in severity of HFpEF.
- Being tested
- GLP-1RA
- Keywords
- HFpEF, Heart Failure preserved Ejection Fraction, Cardiac MRI, Epicardial Adipose Tissue, GLP-1, EAT FAC, cardiovascular function
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1RADrug
Receive 6 months of GLP-1RA (Semaglutide) treatment starting at 0.25mg once weekly and then the dose will be up titrated as tolerated every four weeks to once-weekly doses of 0.5, 1.0, 1.7, and 2.4 mg until a maximum dose of 2.4mg (or the subject's maximally tolerated dose, if the subject's maximally tolerated dose is <2.4 mg) is reached after 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 3D EAT FAC CMR imaging | No intervention | non-contrast MRI to debug/test 3D MRI techniques for quantifying EAT FAC |
| Imaging acquisition and medical condition overview | No intervention | Will undergo Cardiac MRI, exercise echocardiography, 12 lead ECG, medical history review, bloodwork, physical exam, and optional stress cardiac MRI. |
| Imaging acquisition and GLP-1RA treatment | Experimental | Will undergo all testing before and after a 6-month treatment of GLP-1RA Receives: Drug: GLP-1RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial adipose tissue (EAT) fatty acid composition (FAC)
The longitudinal change in epicardial adipose tissue (EAT) fatty acid composition (FAC) [quantified in terms of the fraction of saturated fatty acids (SFA) in units of %] that occur after 6 months of treatment with semaglutide will be compared to the change in SFA that occurred during 3 month period prior to the initiation of semaglutide.
Measured: Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment)
Secondary outcomes (3)
EAT Volume
The longitudinal change in epicardial adipose tissue (EAT) volume (ml) that occurs after 6 months of treatment with semaglutide will be compared to the change in SFA that occurred during 3 month period prior to the initiation of semaglutide.
Measured: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in Myocardial Deformation
The cohort will be divided into 2 groups based on the median value of the epicardial adipose tissue saturated fatty acid composition. The change in global strain (%) following treatment with semaglutide will be compared between the groups.
Measured: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in diastolic dysfunction grade
The cohort will be divided into 2 groups based on the median value of the epicardial adipose tissue saturated fatty acid composition. The change in diastolic dysfunction grade following treatment with semaglutide will be compared between the groups.
Measured: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Nov 2025
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Heart Failure Preserved Ejection FractionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Amit R. Patel, University of Virginia
- Investigators
- Amit Patel, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178145
- Sponsor's protocol ID
- 302641
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pfeffer MA, Shah AM, Borlaug BA. Heart Failure With Preserved Ejection Fraction In Perspective. Circ Res. 2019 May 24;124(11):1598-1617. doi: 10.1161/CIRCRESAHA.119.313572.
PubMed 31120821Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
PubMed 37797885Shah SA, Reagan CE, Bresticker JE, Wolpe AG, Good ME, Macal EH, Billcheck HO, Bradley LA, French BA, Isakson BE, Wolf MJ, Epstein FH. Obesity-Induced Coronary Microvascular Disease Is Prevented by iNOS Deletion and Reversed by iNOS Inhibition. JACC Basic Transl Sci. 2023 Feb 1;8(5):501-514. doi: 10.1016/j.jacbts.2022.11.005. eCollection 2023 May.
PubMed 37325396Echols JT, Wang S, Patel AR, Hogwood AC, Abbate A, Epstein FH. Fatty acid composition MRI of epicardial adipose tissue: Methods and detection of proinflammatory biomarkers in ST-segment elevation myocardial infarction patients. Magn Reson Med. 2025 Feb;93(2):519-535. doi: 10.1002/mrm.30285. Epub 2024 Sep 25.
PubMed 39323040Shah SA, Echols JT, Sun C, Wolf MJ, Epstein FH. Accelerated fatty acid composition MRI of epicardial adipose tissue: Development and application to eplerenone treatment in a mouse model of obesity-induced coronary microvascular disease. Magn Reson Med. 2022 Oct;88(4):1734-1747. doi: 10.1002/mrm.29348. Epub 2022 Jun 20.
PubMed 35726367Martel D, Leporq B, Saxena A, Belmont HM, Turyan G, Honig S, Regatte RR, Chang G. 3T chemical shift-encoded MRI: Detection of altered proximal femur marrow adipose tissue composition in glucocorticoid users and validation with magnetic resonance spectroscopy. J Magn Reson Imaging. 2019 Aug;50(2):490-496. doi: 10.1002/jmri.26586. Epub 2018 Dec 12.
PubMed 30548522Martel D, Leporq B, Bruno M, Regatte RR, Honig S, Chang G. Chemical shift-encoded MRI for assessment of bone marrow adipose tissue fat composition: Pilot study in premenopausal versus postmenopausal women. Magn Reson Imaging. 2018 Nov;53:148-155. doi: 10.1016/j.mri.2018.07.001. Epub 2018 Jul 10.
PubMed 30006022Leporq B, Lambert SA, Ronot M, Boucenna I, Colinart P, Cauchy F, Vilgrain V, Paradis V, Van Beers BE. Hepatic fat fraction and visceral adipose tissue fatty acid composition in mice: Quantification with 7.0T MRI. Magn Reson Med. 2016 Aug;76(2):510-8. doi: 10.1002/mrm.25895. Epub 2015 Nov 3.
PubMed 26527483Schneider M, Janas G, Lugauer F, Hoppe E, Nickel D, Dale BM, Kiefer B, Maier A, Bashir MR. Accurate fatty acid composition estimation of adipose tissue in the abdomen based on bipolar multi-echo MRI. Magn Reson Med. 2019 Apr;81(4):2330-2346. doi: 10.1002/mrm.27557. Epub 2018 Oct 28.
PubMed 30368904Bydder M, Girard O, Hamilton G. Mapping the double bonds in triglycerides. Magn Reson Imaging. 2011 Oct;29(8):1041-6. doi: 10.1016/j.mri.2011.07.004. Epub 2011 Aug 24.
PubMed 21868182Berglund J, Ahlstrom H, Kullberg J. Model-based mapping of fat unsaturation and chain length by chemical shift imaging--phantom validation and in vivo feasibility. Magn Reson Med. 2012 Dec;68(6):1815-27. doi: 10.1002/mrm.24196. Epub 2012 Feb 14.
PubMed 22334300Peterson P, Trinh L, Mansson S. Quantitative 1 H MRI and MRS of fatty acid composition. Magn Reson Med. 2021 Jan;85(1):49-67. doi: 10.1002/mrm.28471. Epub 2020 Aug 25.
PubMed 32844500Ren J, Dimitrov I, Sherry AD, Malloy CR. Composition of adipose tissue and marrow fat in humans by 1H NMR at 7 Tesla. J Lipid Res. 2008 Sep;49(9):2055-62. doi: 10.1194/jlr.D800010-JLR200. Epub 2008 May 28.
PubMed 18509197Johnson LF, Shoolery JN. Determination of Unsaturation and Average Molecular Weight of Natural Fats by Nuclear Magnetic Resonance. Analytical Chemistry 1962;34:1136-1139.
Zou Q, Torres LA, Fain SB, Higano NS, Bates AJ, Jacob M. Dynamic imaging using motion-compensated smoothness regularization on manifolds (MoCo-SToRM). Phys Med Biol. 2022 Jul 4;67(14):10.1088/1361-6560/ac79fc. doi: 10.1088/1361-6560/ac79fc.
PubMed 35714617
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI of Epicardial Adipose Tissue Composition: Development of Methods and Application to Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07178145
- Acronym / sponsor ID
- 302641
- Keywords
- HFpEF, Heart Failure preserved Ejection Fraction, Cardiac MRI, Epicardial Adipose Tissue, GLP-1, EAT FAC, cardiovascular function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Sep 2025 (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.
This study seeks to develop improved cardiac MRI (CMR) methods to quantify epicardial adipose tissue (EAT) composition and to demonstrate the advantages of EAT composition imaging (a) in advancing the understanding of the relationship between EAT and heart failure with preserved ejection fraction (HFpEF) and (b) for understanding mechanisms of and guiding medical therapy in HFpEF. The investigators recently developed the first method for quantifying EAT FAC in human subjects, utilizing a rate-6 accelerated radial 2D multi-echo gradient-echo breathhold acquisition with a local low rank reconstruction. In this project the first specific aim is to develop a rapid free-breathing 3D EAT FAC MRI method that reduces motion-related artifacts, increases coverage, and facilitates higher spatial resolution and improved FAC reproducibility. The second specific aim is to show that EAT FAC is more strongly associated than EAT volume with cardiometabolic HFpEF. In this context, individuals with known or suspected HFpEF will undergo CMR, echocardiography, and other testing to (a) diagnose cardiometabolic HFpEF; (b) characterize features associated with the severity of HFpEF; and (c) assess EAT volume and FAC. The investigators will determine if EAT FAC is more strongly associated than EAT volume with HFpEF and with features associated with the severity of HFpEF. The third specific aim is to show, in the context of cardiometabolic HFpEF and pre-HFpEF, (a) that GLP-1 receptor agonism with semaglutide (SEMA) shifts the EAT FAC to a less proinflammatory profile and (b) that baseline EAT FAC is a stronger predictor than EAT volume of improved cardiovascular function due to SEMA. Cardiometabolic HFpEF and pre-HFpEF subjects will undergo echocardiography and CMR with EAT FAC at baseline and after 3 months to serve as a self-control. Subjects will then undergo repeat imaging 6 months after the initiation of SEMA. The change in FAC after treatment with SEMA will be compared to the change in FAC prior to SEMA. Data will be analyzed to show that SEMA changes EAT FAC, and that baseline EAT FAC is a stronger predictor than EAT volume of improvements in severity of HFpEF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3D EAT FAC CMR imaging | No intervention | –non-contrast MRI to debug/test 3D MRI techniques for quantifying EAT FAC |
| Imaging acquisition and medical condition overview | No intervention | –Will undergo Cardiac MRI, exercise echocardiography, 12 lead ECG, medical history review, bloodwork, physical exam, and optional stress cardiac MRI. |
| Imaging acquisition and GLP-1RA treatment | Experimental | Drug: GLP-1RAWill undergo all testing before and after a 6-month treatment of GLP-1RA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years - 90 years;
- LVEF ≥ 50%;
- ≥ 2 risk factors for HFpEF or symptoms that could be related to HFpEF (e.g., dyspnea, orthopnea, paroxysmal nocturnal dyspnea, lower extremity edema, pulmonary edema, etc);
- Not currently being treated with GLP-1RA therapy.
Key exclusion criteria (23 listed)
- • Previously or currently reduced EF (<50%), including heart transplant; (2) Obstructive un-revascularized coronary disease by coronary CT or invasive coronary angiography;
- Exclusion Criteria for Optional Cardiac Stress Imaging Procedure
- allergy to gadolinium-based contrast agents
- Acute kidney injury
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
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 |
|---|---|---|
| GLP-1RAReceive 6 months of GLP-1RA (Semaglutide) treatment starting at 0.25mg once weekly and then the dose will be up titrated as tolerated every four weeks to once-weekly doses of 0.5, 1.0, 1.7, and 2.4 mg until a maximum dose of 2.4mg (or the subject's maximally tolerated dose, if the subject's maximally tolerated dose is <2.4 mg) is reached after 16 weeks. | Drug | Imaging acquisition and GLP-1RA treatment |
Primary outcome
Epicardial adipose tissue (EAT) fatty acid composition (FAC)
Time frame: Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment)
The longitudinal change in epicardial adipose tissue (EAT) fatty acid composition (FAC) [quantified in terms of the fraction of saturated fatty acids (SFA) in units of %] that occur after 6 months of treatment with semaglutide will be compared to the change in SFA that occurred during 3 month period prior to the initiation of semaglutide.
3 secondary outcomes
EAT Volume
Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in Myocardial Deformation
Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in diastolic dysfunction grade
Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
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 11 Aug 2026.
- Background: PubMed 31120821Pfeffer MA, Shah AM, Borlaug BA. Heart Failure With Preserved Ejection Fraction In Perspective. Circ Res. 2019 May 24;124(11):1598-1617. doi: 10.1161/CIRCRESAHA.119.313572.
- Background: PubMed 37797885Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
- Background: PubMed 37325396Shah SA, Reagan CE, Bresticker JE, Wolpe AG, Good ME, Macal EH, Billcheck HO, Bradley LA, French BA, Isakson BE, Wolf MJ, Epstein FH. Obesity-Induced Coronary Microvascular Disease Is Prevented by iNOS Deletion and Reversed by iNOS Inhibition. JACC Basic Transl Sci. 2023 Feb 1;8(5):501-514. doi: 10.1016/j.jacbts.2022.11.005. eCollection 2023 May.
- Background: PubMed 39323040Echols JT, Wang S, Patel AR, Hogwood AC, Abbate A, Epstein FH. Fatty acid composition MRI of epicardial adipose tissue: Methods and detection of proinflammatory biomarkers in ST-segment elevation myocardial infarction patients. Magn Reson Med. 2025 Feb;93(2):519-535. doi: 10.1002/mrm.30285. Epub 2024 Sep 25.
- Background: PubMed 35726367Shah SA, Echols JT, Sun C, Wolf MJ, Epstein FH. Accelerated fatty acid composition MRI of epicardial adipose tissue: Development and application to eplerenone treatment in a mouse model of obesity-induced coronary microvascular disease. Magn Reson Med. 2022 Oct;88(4):1734-1747. doi: 10.1002/mrm.29348. Epub 2022 Jun 20.
- Background: PubMed 30548522Martel D, Leporq B, Saxena A, Belmont HM, Turyan G, Honig S, Regatte RR, Chang G. 3T chemical shift-encoded MRI: Detection of altered proximal femur marrow adipose tissue composition in glucocorticoid users and validation with magnetic resonance spectroscopy. J Magn Reson Imaging. 2019 Aug;50(2):490-496. doi: 10.1002/jmri.26586. Epub 2018 Dec 12.
- Background: PubMed 30006022Martel D, Leporq B, Bruno M, Regatte RR, Honig S, Chang G. Chemical shift-encoded MRI for assessment of bone marrow adipose tissue fat composition: Pilot study in premenopausal versus postmenopausal women. Magn Reson Imaging. 2018 Nov;53:148-155. doi: 10.1016/j.mri.2018.07.001. Epub 2018 Jul 10.
- Background: PubMed 26527483Leporq B, Lambert SA, Ronot M, Boucenna I, Colinart P, Cauchy F, Vilgrain V, Paradis V, Van Beers BE. Hepatic fat fraction and visceral adipose tissue fatty acid composition in mice: Quantification with 7.0T MRI. Magn Reson Med. 2016 Aug;76(2):510-8. doi: 10.1002/mrm.25895. Epub 2015 Nov 3.
- Background: PubMed 30368904Schneider M, Janas G, Lugauer F, Hoppe E, Nickel D, Dale BM, Kiefer B, Maier A, Bashir MR. Accurate fatty acid composition estimation of adipose tissue in the abdomen based on bipolar multi-echo MRI. Magn Reson Med. 2019 Apr;81(4):2330-2346. doi: 10.1002/mrm.27557. Epub 2018 Oct 28.
- Background: PubMed 21868182Bydder M, Girard O, Hamilton G. Mapping the double bonds in triglycerides. Magn Reson Imaging. 2011 Oct;29(8):1041-6. doi: 10.1016/j.mri.2011.07.004. Epub 2011 Aug 24.
- Background: PubMed 22334300Berglund J, Ahlstrom H, Kullberg J. Model-based mapping of fat unsaturation and chain length by chemical shift imaging--phantom validation and in vivo feasibility. Magn Reson Med. 2012 Dec;68(6):1815-27. doi: 10.1002/mrm.24196. Epub 2012 Feb 14.
- Background: PubMed 32844500Peterson P, Trinh L, Mansson S. Quantitative 1 H MRI and MRS of fatty acid composition. Magn Reson Med. 2021 Jan;85(1):49-67. doi: 10.1002/mrm.28471. Epub 2020 Aug 25.
- Individual participant dataSharing planned: Undecided
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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.
Amit Patel, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLP-1RA in people with Heart Failure Preserved Ejection Fraction and Epicardial Adipose Tissue, run by University of Virginia 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 4 inclusion and 23 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 11 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Medard Ng (434-982-1058, HTN3U@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial adipose tissue (EAT) fatty acid composition (FAC) (time frame: Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178145, which also lists 38 linked publications.
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 11 Aug 2026.