Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging (SWEET-HEART)

Matthieu Pelletier-Galarneau, MD MSc

Status: Completed

Conditions: Myocardial Suppression

Treatments: Other: Fast + High-fat low-carbohydrate diet; Combination Product: Fast + Empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT06350903

ICM 2024-3356

Details and patient eligibility

About

The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.

Full description

The overall objective of this study is to assess if the SGLT2 inhibitor empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. This study will evaluate if an acute administration of empagliflozin (tablets of 10 and/or 25 mg) combined with fasting can sufficiently increase the BHB levels, a proxy of myocardial FDG uptake.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 18 to 70 years
2. Ability to follow the HFLC diet
3. Ability to provide informed consent

Exclusion criteria

1. Treated with SGLT2 inhibitors
2. History of hypersensitivity or allergy to empagliflozin
3. Hypotension with blood pressure <100/65 mmHg
4. Strict vegan
5. Pregnancy
6. Breastfeeding
7. Type I or type II diabetes
8. Renal failure with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.72m2
9. Receiving steroids
10. History of diabetic ketoacidosis (DKA)
11. History of hypoglycemia
12. Any condition that, in the opinion of the investigator, could compromise the participation in the study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)