Cardiac SarcoidosisNCT06510894
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
An observational study of Cardiac Sarcoidosis, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- Sotagliflozin
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to 31 Dec 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 40 evaluable healthy volunteers
Who may be able to join
- Adult patients, at least 18 years of age
- No history of cardiovascular disease, including hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
- No history of chronic liver or kidney disease per medical record review and/or self-report.
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Who cannot join
- Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test during the screening visit and prior to FDG injection.
- Participants who are currently taking diuretics for any indication.
- Participants with an eGFR level <30 mL/min/1.73m2.
- Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
- Any other medical or psychological condition that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
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 Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary E Hansbury, 2157468192, mary.hansbury@pennmedicine.upenn.edu
Erin Schubert, erin.schubert@pennmedicine.upenn.edu
About this study
Official title: Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
- undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
- take the provided sotagliflozin as instructed for 7 days leading up to the scan
- follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
- undergo an FDG PET/CT scan, which includes vitals and blood draws
Read the detailed description
The purpose of this mechanistic pilot study is to evaluate the effect on myocardial glucose suppression, and therefore on image quality, with the addition of a brief course of an FDA approved SGLT1/2 inhibitor prior to FDG PET/CT scan. FDG PET/CT is a clinically utilized scan for diagnosis of cardiac sarcoidosis following the standard diet and fasting requirements, this study will test the addition of the 7 days of sotagliflozin prior to the scan.
Sotagliflozin (INPEFA™) is a sodium-glucose cotransporter-2 inhibitor (SGLT1/2i) Sodium-glucose cotransporter-2 inhibitor that has been studied in humans and is FDA approved for reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. In this study, the investigators will be using it "off-label" in healthy volunteers and will be using only a short course (approximately 1 week) of the drug prior to the FDG PET/CT PET scan. "Off-label" use is when an FDA approved drug is prescribed for a condition/use other than that for which the drug has been officially approved. Therefore, the study will be utilizing sotagliflozin in way that it has yet to be approved for by the FDA.
The investigators may enroll up to 40 fully evaluable healthy volunteers. A fully evaluable subject must complete the PET/CT scan. Subjects who do not complete the PET/CT scan will not be counted as fully evaluable, however, collected data may still be used in some secondary analyses. The participants will be aged at least 18 years old. After completing a screening visit and meeting study eligibility, each participant will undergo an FDG PET scan after taking sotagliflozin for 7 (up to 10 maximum) days and following a ketogenic diet for either 1 day (N=20) prior to the scan with overnight fasting or 3 days (N=20) prior to the scan with overnight fasting. Enrollment of the 20 participants undergoing 3 days of KD is dependent on sufficient funding, and therefore initial efforts will be targeted toward enrolling participants in the 1 day of KD stratum. Participants will be asked to track when they have taken the sotagliflozin in a provided diary.
FDG PET/CT imaging will be used to evaluate glycolytic activity in the heart using the FDA approved clinical Positron Emission Tomography (PET) radiotracer, [18F] Fluorodeoxyglucose (FDG) Imaging will be done on a dedicated whole-body PET scanner. For each PET scan, dynamic images over the body will be acquired from the time of injection to up to 60 minutes after injection of FDG. Imaging data will be processed as per standard protocols. The study will be performed under the regulatory approval of the Penn Institutional Review Board (IRB).
Participants will undergo an FDG PET/CT after taking 7 (up to 10 maximum) days of oral sotagliflozin overlapping with 1 or 3 day(s) of dietary modification (standard ketogenic diet) and overnight fasting prior to FDG injection.
For all subjects, the investigators may measure blood levels of BHB, lipids, basic metabolic panel, complete blood counts HbA1c, free fatty acid, acylcarnitine, glucose, and insulin at screening, some of these tests will be repeated on the day of the scan. The investigators plan to use the Penn Metabolomics Core and Penn Diabetes Radioimmunoassay and Biomarkers Core for sample processing. Since intravenous access will be obtained for administration of the tracer on the day of the PET scan, a blood draw will be performed from this line. Thereafter, the investigators will perform comprehensive, targeted metabolomic profiling from this peripheral blood so the study team can correlate myocardial suppression with other metabolic markers. Most of the research testing will occur at later dates with stored samples. The lab test results that may be entered in the medical record include BHB, lipids, basic metabolic panel, complete blood counts and glucose. Other experimental test results will not be provided to the subjects.
Participants will be asked to follow a standard prescribed ketogenic diet and keep a diet diary during the KD prior to the FDG PET visit, this diet matches the clinical SOC pre-scan preparation for sarcoidosis. On the day of FDG-PET, the diet diary will be collected and reviewed by an investigator. The diet will also be reviewed, usually at a later date, by a CHPS nutritional specialist and information reported by the subject will be used to perform meal analysis and estimate grams of fat, protein and carbohydrates.
This is a single institution, pilot mechanistic study of FDG PET/CT to determine optimal method of myocardial glucose suppression. Patients may participate in this study if they are greater than 18 years of age. Subjects that may meet eligibility criteria will be approached about study participation regardless of race or ethnic background.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- Sotagliflozin
- Keywords
- sarcoidosis, Cardiac Sacroidosis, SGLT1/2 Inhibition, Myocardial Glucose Suppression, Ketogenic Diet, sotagliflozin, Healthy volunteer, PET/CT
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Also called INPEFA
Sodium-glucose cotransporter-1/2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet with sotagliflozin | 40 volunteers will take a SGLT1/2i, sotagliflozin (400 mg QD), for 7 days prior to the PET scan visit and will undergo FDG PET/CT after 1-3 day of dietary modification (ketogenic diet for at least 3-9 meals) and overnight fasting prior to FDG injection. Receives: Drug: Sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete myocardial glucose suppression
Rate of complete myocardial glucose suppression after 7-day regimen of sotagliflozin
Measured: 7 days
Secondary outcomes (1)
Myocardial glucose utilization
Myocardial glucose utilization in FDG PET/CT measured by SUV in the heart
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start20 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Paco Bravo, MD, University of Pennsylvania
- Investigators
- Paco Bravo, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510894
- Sponsor's protocol ID
- 855451
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LONGCOPE WT, FREIMAN DG. A study of sarcoidosis; based on a combined investigation of 160 cases including 30 autopsies from The Johns Hopkins Hospital and Massachusetts General Hospital. Medicine (Baltimore). 1952 Feb;31(1):1-132. No abstract available.
PubMed 14899212Silverman KJ, Hutchins GM, Bulkley BH. Cardiac sarcoid: a clinicopathologic study of 84 unselected patients with systemic sarcoidosis. Circulation. 1978 Dec;58(6):1204-11. doi: 10.1161/01.cir.58.6.1204.
PubMed 709777Sharma OP, Maheshwari A, Thaker K. Myocardial sarcoidosis. Chest. 1993 Jan;103(1):253-8. doi: 10.1378/chest.103.1.253. No abstract available.
PubMed 8417889Kron J, Sauer W, Schuller J, Bogun F, Crawford T, Sarsam S, Rosenfeld L, Mitiku TY, Cooper JM, Mehta D, Greenspon AJ, Ortman M, Delurgio DB, Valadri R, Narasimhan C, Swapna N, Singh JP, Danik S, Markowitz SM, Almquist AK, Krahn AD, Wolfe LG, Feinstein S, Ellenbogen KA. Efficacy and safety of implantable cardiac defibrillators for treatment of ventricular arrhythmias in patients with cardiac sarcoidosis. Europace. 2013 Mar;15(3):347-54. doi: 10.1093/europace/eus316. Epub 2012 Sep 21.
PubMed 23002195Hiramitsu S, Morimoto S, Uemura A, Kato Y, Kimura K, Ohtsuki M, Kato S, Sugiura A, Miyagishima K, Hishida H, Sugisaki K, Tsuda T. National survey on status of steroid therapy for cardiac sarcoidosis in Japan. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Oct;22(3):210-3.
PubMed 16315784Maurer AH, Burshteyn M, Adler LP, Gaughan JP, Steiner RM. Variable cardiac 18FDG patterns seen in oncologic positron emission tomography computed tomography: importance for differentiating normal physiology from cardiac and paracardiac disease. J Thorac Imaging. 2012 Jul;27(4):263-8. doi: 10.1097/RTI.0b013e3182176675.
PubMed 21629130Cheng VY, Slomka PJ, Ahlen M, Thomson LE, Waxman AD, Berman DS. Impact of carbohydrate restriction with and without fatty acid loading on myocardial 18F-FDG uptake during PET: A randomized controlled trial. J Nucl Cardiol. 2010 Apr;17(2):286-91. doi: 10.1007/s12350-009-9179-5. Epub 2009 Dec 15.
PubMed 20013165Harisankar CN, Mittal BR, Agrawal KL, Abrar ML, Bhattacharya A. Utility of high fat and low carbohydrate diet in suppressing myocardial FDG uptake. J Nucl Cardiol. 2011 Oct;18(5):926-36. doi: 10.1007/s12350-011-9422-8. Epub 2011 Jul 6.
PubMed 21732228BING RJ, SIEGEL A, UNGAR I, GILBERT M. Metabolism of the human heart. II. Studies on fat, ketone and amino acid metabolism. Am J Med. 1954 Apr;16(4):504-15. doi: 10.1016/0002-9343(54)90365-4. No abstract available.
PubMed 13148192Alfawara MS, Ahmed AI, Saad JM, Han Y, Alahdab F, Al Rifai M, Kassi M, Alnabelsi T, Zoghbi WA, Al-Mallah MH. The utility of beta-hydroxybutyrate in detecting myocardial glucose uptake suppression in patients undergoing inflammatory [18F]-FDG PET studies. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1103-1110. doi: 10.1007/s00259-022-06062-7. Epub 2022 Dec 7.
PubMed 36474124Madamanchi C, Weinberg RL, Murthy VL. Utility of serum ketone levels for assessment of myocardial glucose suppression for 18F-fluorodeoxyglucose PET in patients referred for evaluation of endocarditis. J Nucl Cardiol. 2023 Jun;30(3):928-937. doi: 10.1007/s12350-023-03209-3. Epub 2023 Feb 23.
PubMed 36823484Selvaraj S, Margulies KB, Dugyala S, Schubert E, Tierney A, Arany Z, Pryma DA, Shah SH, Rame JE, Kelly DP, Bravo PE. Comparison of Exogenous Ketone Administration Versus Dietary Carbohydrate Restriction on Myocardial Glucose Suppression: A Crossover Clinical Trial. J Nucl Med. 2022 May;63(5):770-776. doi: 10.2967/jnumed.121.262734. Epub 2021 Oct 21.
PubMed 34675108Selvaraj S, Fu Z, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Newgard CB, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Lanfear DE, Nassif ME, Javaheri A, Mentz RJ, Kosiborod MN, Shah SH; DEFINE-HF Investigators. Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF. Circulation. 2022 Sep 13;146(11):808-818. doi: 10.1161/CIRCULATIONAHA.122.060402. Epub 2022 May 23.
PubMed 35603596Selvaraj S, Kelly DP, Margulies KB. Implications of Altered Ketone Metabolism and Therapeutic Ketosis in Heart Failure. Circulation. 2020 Jun 2;141(22):1800-1812. doi: 10.1161/CIRCULATIONAHA.119.045033. Epub 2020 Jun 1.
PubMed 32479196Lauritsen KM, Nielsen BRR, Tolbod LP, Johannsen M, Hansen J, Hansen TK, Wiggers H, Moller N, Gormsen LC, Sondergaard E. SGLT2 Inhibition Does Not Affect Myocardial Fatty Acid Oxidation or Uptake, but Reduces Myocardial Glucose Uptake and Blood Flow in Individuals With Type 2 Diabetes: A Randomized Double-Blind, Placebo-Controlled Crossover Trial. Diabetes. 2021 Mar;70(3):800-808. doi: 10.2337/db20-0921. Epub 2020 Dec 17.
PubMed 33334875
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
- ClinicalTrials.gov ID
- NCT06510894
- Acronym / sponsor ID
- 855451
- Conditions
- Cardiac Sarcoidosis
- Keywords
- sarcoidosis, Cardiac Sacroidosis, SGLT1/2 Inhibition, Myocardial Glucose Suppression, Ketogenic Diet, sotagliflozin, Healthy volunteer, PET/CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jul 2024 (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 is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
- undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
- take the provided sotagliflozin as instructed for 7 days leading up to the scan
- follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
- undergo an FDG PET/CT scan, which includes vitals and blood draws
Detailed description
The purpose of this mechanistic pilot study is to evaluate the effect on myocardial glucose suppression, and therefore on image quality, with the addition of a brief course of an FDA approved SGLT1/2 inhibitor prior to FDG PET/CT scan. FDG PET/CT is a clinically utilized scan for diagnosis of cardiac sarcoidosis following the standard diet and fasting requirements, this study will test the addition of the 7 days of sotagliflozin prior to the scan.
Sotagliflozin (INPEFA™) is a sodium-glucose cotransporter-2 inhibitor (SGLT1/2i) Sodium-glucose cotransporter-2 inhibitor that has been studied in humans and is FDA approved for reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. In this study, the investigators will be using it "off-label" in healthy volunteers and will be using only a short course (approximately 1 week) of the drug prior to the FDG PET/CT PET scan. "Off-label" use is when an FDA approved drug is prescribed for a condition/use other than that for which the drug has been officially approved. Therefore, the study will be utilizing sotagliflozin in way that it has yet to be approved for by the FDA.
The investigators may enroll up to 40 fully evaluable healthy volunteers. A fully evaluable subject must complete the PET/CT scan. Subjects who do not complete the PET/CT scan will not be counted as fully evaluable, however, collected data may still be used in some secondary analyses. The participants will be aged at least 18 years old. After completing a screening visit and meeting study eligibility, each participant will undergo an FDG PET scan after taking sotagliflozin for 7 (up to 10 maximum) days and following a ketogenic diet for either 1 day (N=20) prior to the scan with overnight fasting or 3 days (N=20) prior to the scan with overnight fasting. Enrollment of the 20 participants undergoing 3 days of KD is dependent on sufficient funding, and therefore initial efforts will be targeted toward enrolling participants in the 1 day of KD stratum. Participants will be asked to track when they have taken the sotagliflozin in a provided diary.
FDG PET/CT imaging will be used to evaluate glycolytic activity in the heart using the FDA approved clinical Positron Emission Tomography (PET) radiotracer, [18F] Fluorodeoxyglucose (FDG) Imaging will be done on a dedicated whole-body PET scanner. For each PET scan, dynamic images over the body will be acquired from the time of injection to up to 60 minutes after injection of FDG. Imaging data will be processed as per standard protocols. The study will be performed under the regulatory approval of the Penn Institutional Review Board (IRB).
Participants will undergo an FDG PET/CT after taking 7 (up to 10 maximum) days of oral sotagliflozin overlapping with 1 or 3 day(s) of dietary modification (standard ketogenic diet) and overnight fasting prior to FDG injection.
For all subjects, the investigators may measure blood levels of BHB, lipids, basic metabolic panel, complete blood counts HbA1c, free fatty acid, acylcarnitine, glucose, and insulin at screening, some of these tests will be repeated on the day of the scan. The investigators plan to use the Penn Metabolomics Core and Penn Diabetes Radioimmunoassay and Biomarkers Core for sample processing. Since intravenous access will be obtained for administration of the tracer on the day of the PET scan, a blood draw will be performed from this line. Thereafter, the investigators will perform comprehensive, targeted metabolomic profiling from this peripheral blood so the study team can correlate myocardial suppression with other metabolic markers. Most of the research testing will occur at later dates with stored samples. The lab test results that may be entered in the medical record include BHB, lipids, basic metabolic panel, complete blood counts and glucose. Other experimental test results will not be provided to the subjects.
Participants will be asked to follow a standard prescribed ketogenic diet and keep a diet diary during the KD prior to the FDG PET visit, this diet matches the clinical SOC pre-scan preparation for sarcoidosis. On the day of FDG-PET, the diet diary will be collected and reviewed by an investigator. The diet will also be reviewed, usually at a later date, by a CHPS nutritional specialist and information reported by the subject will be used to perform meal analysis and estimate grams of fat, protein and carbohydrates.
This is a single institution, pilot mechanistic study of FDG PET/CT to determine optimal method of myocardial glucose suppression. Patients may participate in this study if they are greater than 18 years of age. Subjects that may meet eligibility criteria will be approached about study participation regardless of race or ethnic background.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet with sotagliflozin | – | Drug: Sotagliflozin40 volunteers will take a SGLT1/2i, sotagliflozin (400 mg QD), for 7 days prior to the PET scan visit and will undergo FDG PET/CT after 1-3 day of dietary modification (ketogenic diet for at least 3-9 meals) and overnight fasting prior to FDG injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 40 evaluable healthy volunteers
Key inclusion criteria (4 listed)
- Adult patients, at least 18 years of age
- No history of cardiovascular disease, including hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
- No history of chronic liver or kidney disease per medical record review and/or self-report.
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Key exclusion criteria (5 listed)
- Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test during the screening visit and prior to FDG injection.
- Participants who are currently taking diuretics for any indication.
- Participants with an eGFR level <30 mL/min/1.73m2.
- Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
- Any other medical or psychological condition that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
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 |
|---|---|---|
| SotagliflozinAlso: INPEFASodium-glucose cotransporter-1/2 inhibitor | Drug | Ketogenic Diet with sotagliflozin |
Primary outcome
Complete myocardial glucose suppression
Time frame: 7 days
Rate of complete myocardial glucose suppression after 7-day regimen of sotagliflozin
1 secondary outcome
Myocardial glucose utilization
Time frame: 7 days
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 7 Jan 2026.
- Results publication: PubMed 14899212LONGCOPE WT, FREIMAN DG. A study of sarcoidosis; based on a combined investigation of 160 cases including 30 autopsies from The Johns Hopkins Hospital and Massachusetts General Hospital. Medicine (Baltimore). 1952 Feb;31(1):1-132. No abstract available.
- Results publication: PubMed 709777Silverman KJ, Hutchins GM, Bulkley BH. Cardiac sarcoid: a clinicopathologic study of 84 unselected patients with systemic sarcoidosis. Circulation. 1978 Dec;58(6):1204-11. doi: 10.1161/01.cir.58.6.1204.
- Results publication: PubMed 8417889Sharma OP, Maheshwari A, Thaker K. Myocardial sarcoidosis. Chest. 1993 Jan;103(1):253-8. doi: 10.1378/chest.103.1.253. No abstract available.
- Results publication: PubMed 23002195Kron J, Sauer W, Schuller J, Bogun F, Crawford T, Sarsam S, Rosenfeld L, Mitiku TY, Cooper JM, Mehta D, Greenspon AJ, Ortman M, Delurgio DB, Valadri R, Narasimhan C, Swapna N, Singh JP, Danik S, Markowitz SM, Almquist AK, Krahn AD, Wolfe LG, Feinstein S, Ellenbogen KA. Efficacy and safety of implantable cardiac defibrillators for treatment of ventricular arrhythmias in patients with cardiac sarcoidosis. Europace. 2013 Mar;15(3):347-54. doi: 10.1093/europace/eus316. Epub 2012 Sep 21.
- Results publication: PubMed 16315784Hiramitsu S, Morimoto S, Uemura A, Kato Y, Kimura K, Ohtsuki M, Kato S, Sugiura A, Miyagishima K, Hishida H, Sugisaki K, Tsuda T. National survey on status of steroid therapy for cardiac sarcoidosis in Japan. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Oct;22(3):210-3.
- Results publication: PubMed 21629130Maurer AH, Burshteyn M, Adler LP, Gaughan JP, Steiner RM. Variable cardiac 18FDG patterns seen in oncologic positron emission tomography computed tomography: importance for differentiating normal physiology from cardiac and paracardiac disease. J Thorac Imaging. 2012 Jul;27(4):263-8. doi: 10.1097/RTI.0b013e3182176675.
- Results publication: PubMed 20013165Cheng VY, Slomka PJ, Ahlen M, Thomson LE, Waxman AD, Berman DS. Impact of carbohydrate restriction with and without fatty acid loading on myocardial 18F-FDG uptake during PET: A randomized controlled trial. J Nucl Cardiol. 2010 Apr;17(2):286-91. doi: 10.1007/s12350-009-9179-5. Epub 2009 Dec 15.
- Results publication: PubMed 21732228Harisankar CN, Mittal BR, Agrawal KL, Abrar ML, Bhattacharya A. Utility of high fat and low carbohydrate diet in suppressing myocardial FDG uptake. J Nucl Cardiol. 2011 Oct;18(5):926-36. doi: 10.1007/s12350-011-9422-8. Epub 2011 Jul 6.
- Results publication: PubMed 13148192BING RJ, SIEGEL A, UNGAR I, GILBERT M. Metabolism of the human heart. II. Studies on fat, ketone and amino acid metabolism. Am J Med. 1954 Apr;16(4):504-15. doi: 10.1016/0002-9343(54)90365-4. No abstract available.
- Results publication: PubMed 36474124Alfawara MS, Ahmed AI, Saad JM, Han Y, Alahdab F, Al Rifai M, Kassi M, Alnabelsi T, Zoghbi WA, Al-Mallah MH. The utility of beta-hydroxybutyrate in detecting myocardial glucose uptake suppression in patients undergoing inflammatory [18F]-FDG PET studies. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1103-1110. doi: 10.1007/s00259-022-06062-7. Epub 2022 Dec 7.
- Results publication: PubMed 36823484Madamanchi C, Weinberg RL, Murthy VL. Utility of serum ketone levels for assessment of myocardial glucose suppression for 18F-fluorodeoxyglucose PET in patients referred for evaluation of endocarditis. J Nucl Cardiol. 2023 Jun;30(3):928-937. doi: 10.1007/s12350-023-03209-3. Epub 2023 Feb 23.
- Results publication: PubMed 34675108Selvaraj S, Margulies KB, Dugyala S, Schubert E, Tierney A, Arany Z, Pryma DA, Shah SH, Rame JE, Kelly DP, Bravo PE. Comparison of Exogenous Ketone Administration Versus Dietary Carbohydrate Restriction on Myocardial Glucose Suppression: A Crossover Clinical Trial. J Nucl Med. 2022 May;63(5):770-776. doi: 10.2967/jnumed.121.262734. Epub 2021 Oct 21.
- Individual participant dataSharing planned: No
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Sarcoidosis
Recruiting
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
Cardiac Sarcoidosis, Infective Endocarditis
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
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.
Paco Bravo, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sarcoidosis, run by University of Pennsylvania 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 5 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 7 Jan 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.
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 Mary E Hansbury, BS (2157468192, mary.hansbury@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete myocardial glucose suppression (time frame: 7 days). 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 NCT06510894, which also lists 17 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 7 Jan 2026.