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

NCT07231939 | Recruiting

• 1 other identifier: FLORENCE
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Acute Kidney Injury; Contrast-Induced Acute Kidney Injury; Percutaneous Coronary Intervention

Keywords

AKI; contrast-induced acute kidney injury; PCI; coronary angiography; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)

  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 Outcomes (6)

• Creatinine change after coronary procedure

  0-72 hours

• eGFR after coronary procedure

  0-72 hours

• Real-life incidence of AKI

  0-72 hours

• incidence of CI-AKI in diabetic patients

  0-72 hours

• incidence of CI-AKI in ACS patients using flozins

  0-72 hours

Study Arms (2)

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 not using any flozin

Patients who underwent percutaneous coronary interventions but were not using any flozins

Interventions

Flozin DRUG

Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin

Also known as: Empagliflozin, Jardiance, Dapagliflozin, Forxiga

Patients using any flozin at the time of coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Collegium Medicum w Bydgoszczy

Bydgoszcz, 85-094, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Acute Kidney Injury

Interventions

empagliflozin; dapagliflozin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jacek Kubica, Prof.

  Collegium Medicum w Bydgoszczy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Niezgoda, MD, PhD

CONTACT

+48525854023; piotr.niezgoda1986@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)