Coronary Artery DiseaseFLORENCENCT07231939
Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI
An observational study of Coronary Artery Disease and Acute Kidney Injury, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Kidney Injury, Contrast-Induced Acute Kidney Injury
- What is being tested?
- Flozin
- How many people
- 4,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available
Who cannot join
- unavailability of variables required for the analysis, volume
- contrast agent volume <50 mL or >500 mL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Collegium Medicum w Bydgoszczy
Bydgoszcz, 85-094
Piotr Niezgoda, MD, PhD, +48525854023, piotr.niezgoda1986@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Acute Kidney Injury, Contrast-Induced Acute Kidney Injury, Percutaneous Coronary Intervention
- Being tested
- Flozin
- Keywords
- AKI, contrast-induced acute kidney injury, PCI, coronary angiography, acute kidney injury
- Medical subject headings
- Coronary Artery Disease, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlozinDrug
Also called Empagliflozin, Jardiance, Dapagliflozin, Forxiga
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Flozin | |
| Patients not using any flozin | Patients who underwent percutaneous coronary interventions but were not using any flozins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-72 hours
Secondary outcomes (6)
Creatinine change after coronary procedure
Change in serum creatinine concentration before and after the index procedure
Measured: 0-72 hours
eGFR after coronary procedure
Change in eGFR before and after the index procedure
Measured: 0-72 hours
Real-life incidence of AKI
the true incidence of CI-AKI in real-world clinical setting
Measured: 0-72 hours
incidence of CI-AKI in diabetic patients
the effect of SGLTi on the occurrence of CI-AKI in patients with and without type 2 diabetes mellitus
Measured: 0-72 hours
incidence of CI-AKI in ACS patients using flozins
the effect of SGLTi on the occurrence of CI-AKI in patients with and without acute coronary syndrome
Measured: 0-72 hours
incidence of CI-AKI on empagliflozin vs dapagliflozin
the effects of dapagliflozin versus empagliflozin on the occurrence of CI-AKI in the overall study population
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Nov 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, Prof., Principal investigator, Collegium Medicum w Bydgoszczy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231939
- Sponsor's protocol ID
- FLORENCE
- Acronym
- FLORENCE
- Status last verified
- Oct 2025
- First submitted
- 29 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study
- ClinicalTrials.gov ID
- NCT07231939
- Acronym / sponsor ID
- FLORENCE / FLORENCE
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients using any flozin at the time of coronary intervention | – | Drug: FlozinPatients who underwent percutaneous coronary procedures while using empagliflozin or dapagliflozin in a standard 10 mg daily dose |
| Patients not using any flozin | – | –Patients who underwent percutaneous coronary interventions but were not using any flozins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available
Key exclusion criteria (2 listed)
- unavailability of variables required for the analysis, volume
- contrast agent volume <50 mL or >500 mL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlozinAlso: Empagliflozin, Jardiance, Dapagliflozin, ForxigaPatients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin | Drug | Patients using any flozin at the time of coronary intervention |
Primary outcome
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
6 secondary outcomes
Creatinine change after coronary procedure
Time frame: 0-72 hours
eGFR after coronary procedure
Time frame: 0-72 hours
Real-life incidence of AKI
Time frame: 0-72 hours
incidence of CI-AKI in diabetic patients
Time frame: 0-72 hours
incidence of CI-AKI in ACS patients using flozins
Time frame: 0-72 hours
incidence of CI-AKI on empagliflozin vs dapagliflozin
Time frame: 0-72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacek Kubica, Prof. principal investigator
Collegium Medicum w Bydgoszczy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Kidney Injury, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Niezgoda, MD, PhD (+48525854023, piotr.niezgoda1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI) (time frame: 0-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.