Effect of Empagliflozin on Inflammation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHotel Dieu de France Hospital
About this trial
Empagliflozin is a drug given to lower glucose. It is used in the treatment of diabetes. However, it was shown to improve symptoms and survival of patients who are suffering from heart failure. The exact mechanism of this effect is currently not clearly understood.
He hypothesize that empagliflozin has other properties than glucose lowering, that can explain its efficacy. One of these properties, is an anti-inflammatory effect.
To document this, we are using a model of inflammation following percutaneous coronary scenting. We know that patients who get a stent will develop inflammation following stenting. This is documenting by a higher level of C-Reactive Protein 24 hours after the procedure.
Patients who will participate in the study, will receive empagliflozin or a placebo tablet for 3 days prior to the revascularisation procedure. CRP and other inflammatory markers will be measured before intervention and 24 hours later. The goal is to demonstrate a lower rise in CRP following intervention in patients treated with empagliflozin vs. those who have received a placebo.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery
Disqualifiers
• Patients who have been taking an SGLT-2 inhibitor during the last month
Patients who are receiving any anti-inflammatory medication: immunosuppressor, steroids, NSAID…
Patients who have underlying inflammatory conditions such as rheumatic arthritis, infection, active malignancy
Patients with an acute coronary syndrome within the last month
Trial design
Design model
Parallel
Treatments tested in this trial
Empagliflozin (SGLT2i)
DrugPatient will receive 10 mg of empagliflozin PO per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention
Placebo
DrugPatient will receive a matching placebo PO 1 tab per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: empagliflozinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
CRP change
High sensitivity CRP will be measured immediately before and 18-24 hours after PCI
Time frame
baseline and 18-24 hours after pciSponsors and contacts
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Source ClinicalTrials.gov