Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI (FLORENCE)

November 14, 2025 updated by: Jacek Kubica, Collegium Medicum w Bydgoszczy

FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study

All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion.

The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.

The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The use of radiological imaging methods requiring iodine-based contrast media (ICM) has been steadily increasing in recent years. Contrast-induced acute kidney injury (CI-AKI), formerly referred to as contrast-induced nephropathy (CIN), is one of the most common causes of acute kidney injury in patients undergoing diagnostic or therapeutic procedures involving ICM.

The study was designed as a retrospective, single-centre, cross-sectional, cohort, case-control study. All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion. The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.

The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.

The analysis of the baseline characteristics of the study population is planned.

Based on the results of the study, a meta-analysis combining the results of previously published studies with those of the present study will be performed.

Key variables to be analyzed: type and volume of ICM; serum creatinine concentration at baseline, 24 h, 48 h, and 72 h after the procedure; eGFR at baseline, 24 h, 48 h, and 72 h; use of SGLT2i within 3 days prior to the procedure; long-term use of SGLT2i; type of SGLT2i administered.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective analysis of data obtained from patients hospitalized between 2020 and 2025 in the Department of Cardiology and Internal Medicine, who underwent coronary angiography or PCI.

The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available

Description

Inclusion Criteria:

  • all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available

Exclusion Criteria:

  • unavailability of variables required for the analysis, volume
  • contrast agent volume <50 mL or >500 mL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients using any flozin at the time of coronary intervention
Patients who underwent percutaneous coronary procedures while using empagliflozin or dapagliflozin in a standard 10 mg daily dose
Drug: Flozin
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin
Other Names:
  • Forxiga
  • Jardiance
  • Dapagliflozin
  • Empagliflozin
Patients not using any flozin
Patients who underwent percutaneous coronary interventions but were not using any flozins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)
Time Frame: 0-72 hours
Occurrence of CI-AKI defined as an increase in serum creatinine concentration of ≥0.5 mg/dL (44.2 μmol/L) or >25% compared with baseline within 72 h after intravascular administration a contrast medium agent
0-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creatinine change after coronary procedure
Time Frame: 0-72 hours
Change in serum creatinine concentration before and after the index procedure
0-72 hours
eGFR after coronary procedure
Time Frame: 0-72 hours
Change in eGFR before and after the index procedure
0-72 hours
Real-life incidence of AKI
Time Frame: 0-72 hours
the true incidence of CI-AKI in real-world clinical setting
0-72 hours
incidence of CI-AKI in diabetic patients
Time Frame: 0-72 hours
the effect of SGLTi on the occurrence of CI-AKI in patients with and without type 2 diabetes mellitus
0-72 hours
incidence of CI-AKI in ACS patients using flozins
Time Frame: 0-72 hours
the effect of SGLTi on the occurrence of CI-AKI in patients with and without acute coronary syndrome
0-72 hours
incidence of CI-AKI on empagliflozin vs dapagliflozin
Time Frame: 0-72 hours
the effects of dapagliflozin versus empagliflozin on the occurrence of CI-AKI in the overall study population
0-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collegium Medicum w Bydgoszczy

Investigators

  • Principal Investigator: Jacek Kubica, Prof., Collegium Medicum w Bydgoszczy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLORENCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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