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NCT Number: NCT07231939

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flozin

Drug

Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin

Other names: Empagliflozin, Jardiance, Dapagliflozin, Forxiga

Primary outcomes

  1. 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

Secondary outcomes

  1. Creatinine change after coronary procedure

    Time frame: 0-72 hours

    Change in serum creatinine concentration before and after the index procedure

  2. eGFR after coronary procedure

    Time frame: 0-72 hours

    Change in eGFR before and after the index procedure

  3. Real-life incidence of AKI

    Time frame: 0-72 hours

    the true incidence of CI-AKI in real-world clinical setting

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Niezgoda, MD, PhD

CONTACT

[email protected]

+48525854023

Sponsors and collaborators

Lead sponsor

Collegium Medicum w Bydgoszczy

Other

Registry information

Official study title

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

Acronym: FLORENCE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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