Myocardial SuppressionSWEET-HEARTNCT06350903
Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging
A study testing Fast + High-fat low-carbohydrate diet and Fast + Empagliflozin in people with Myocardial Suppression, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Suppression
- What is being tested?
- Fast + High-fat low-carbohydrate diet and Fast + Empagliflozin
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years
- Ability to follow the HFLC diet
- Ability to provide informed consent
Who cannot join
- Treated with SGLT2 inhibitors
- History of hypersensitivity or allergy to empagliflozin
- Hypotension with blood pressure <100/65 mmHg
- Strict vegan
- Pregnancy
- Breastfeeding
Show all 12Show fewer
- Type I or type II diabetes
- Renal failure with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.72m2
- Receiving steroids
- History of diabetic ketoacidosis (DKA)
- History of hypoglycemia
- Any condition that, in the opinion of the investigator, could compromise the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging
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.
Read the detailed 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.
- Conditions
- Myocardial Suppression
- Being tested
- Fast + High-fat low-carbohydrate diet, Fast + Empagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast + High-fat low-carbohydrate dietOther
Participants will be instructed to follow a strict HFLC diet starting on the morning of the day before the visit and to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications.
Fast + EmpagliflozinCombination product
Participants will be instructed to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications. Participants will also be instructed to take an oral dose of 50 mg of empagliflozin at 7am the morning before the experimental visit and on the day of the experimental visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet
Measured: 1 day
Secondary outcomes (3)
Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L
Proportion of participants with serum BHB >0.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.
Measured: 1 day
Proportions of glycemia levels (mmol/L) <3.5 mmol/L
Proportion of participants with glycemia <3.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.
Measured: 1 day
Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.
Proportion of participants who preferred the empagliflozin to the HFLC diet as assessed by a dedicated survey.
Measured: Through study completion, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial SuppressionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350903
- Sponsor's protocol ID
- ICM 2024-3356
- Acronym
- SWEET-HEART
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging
- ClinicalTrials.gov ID
- NCT06350903
- Acronym / sponsor ID
- SWEET-HEART / ICM 2024-3356
- Conditions
- Myocardial Suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MScUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 70 years
- Ability to follow the HFLC diet
- Ability to provide informed consent
Key exclusion criteria (12 listed)
- Treated with SGLT2 inhibitors
- History of hypersensitivity or allergy to empagliflozin
- Hypotension with blood pressure <100/65 mmHg
- Strict vegan
- Pregnancy
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 |
|---|---|---|
| Fast + High-fat low-carbohydrate dietParticipants will be instructed to follow a strict HFLC diet starting on the morning of the day before the visit and to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications. | Other | – |
| Fast + EmpagliflozinParticipants will be instructed to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications. Participants will also be instructed to take an oral dose of 50 mg of empagliflozin at 7am the morning before the experimental visit and on the day of the experimental visit. | Combination product | – |
Primary outcome
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
Time frame: 1 day
Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet
3 secondary outcomes
Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L
Time frame: 1 day
Proportions of glycemia levels (mmol/L) <3.5 mmol/L
Time frame: 1 day
Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.
Time frame: Through study completion, up to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Healthy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast + High-fat low-carbohydrate diet and Fast + Empagliflozin in people with Myocardial Suppression, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 29 Sep 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L (time frame: 1 day). 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 29 Sep 2025.