Effect of Empagliflozin on Inflammation | NCT07292909

Studies
Effect of Empagliflozin on Inflammation

NCT07292909

Sponsor

Hotel Dieu de France Hospital

Status

Recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

CAD - Coronary Artery Disease
Inflamation
PCI
SGLT 2 Inhibitors

Interventions

Empagliflozin (SGLT2i)
Placebo

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2025Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Dec 6, 2025

First Submission Date that Met QC Criteria

Dec 6, 2025

First Posted Date

Dec 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
empagliflozin	Active Comparator	Patients who will receive empagliflozin	Drug: Empagliflozin (SGLT2i)
Placebo	Placebo Comparator	Placebo control	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin (SGLT2i)	Drug	Patient 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRP change	High sensitivity CRP will be measured immediately before and 18-24 hours after PCI	baseline and 18-24 hours after pci

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery

Exclusion Criteria:

• 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
- Intervention on a restenotic lesion or lesion in a saphenous vein graft
- Creatinine clearance less than 30 mL/min
- Patients who are treated with devices other than balloons and stents (lithotripsy, rotational atherectomy…)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rabih R Azar, MD, MPH	Contact	+9613590999		razarmd@hotmail.com
Georges G Hage, MD	Contact	+9613284724		georgesjuniorhage@hotmail.com

Overall Officials

Name	Affiliation	Role
Rabih R Azar, MD, MPH	Hotel Dieu de Frace	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hotel Dieu de France	Recruiting	Beirut	Beirut	00000	Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We can share all patients data: demographics, characteristics of intervention, markers levels before and after the procedure

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

At end of study and for at least 3 years after completion

Access Criteria

Investigators, journal editors. They can contact us via email

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D007249	Inflammation

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570240	empagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided