Investigating the effect of adding sglt2i in preventing kidney failure in patients receiving contrast in coronary angiography -Interventional - Randomized controlled clinical trial

Investigating the Additive Effect of Sodium-Glucose Cotransporter 2 Inhibitors in Preventing Renal Failure in Patients Receiving Contrast Media During Angiography

A randomized, double-blind, placebo-controlled, parallel-group phase 3 trial. Sample: 150 participants (75 per arm). Intervention: Dapagliflozin 10 mg daily vs. matched placebo, initiated ≥3 days pre-angiography and continued for 72 hours post-procedure.

At Shiraz Namazi Hospital, coronary angiography candidates are screened. The intervention group receives dapagliflozin 10 mg/day from 3 days before to 72 hours after angiography. Kidney function is measured at baseline, 24h, 48–72h, and 7 days post-angiography. Primary outcome: contrast-induced acute kidney injury (creatinine increase ≥0.3 mg/dL).

The inclusion criteria are 18 years of age or older, and all patients with normal renal parameters who underwent coronary angiography with contrast agents will be included in the study. In addition, patients with EGFR ≤ 30 mL/min will also be included in this study. Exclusion criteria: Patients with known chronic kidney disease, baseline creatinine greater than 1.5 mg/dL, significant hypotension, anemia, and patients with acute myocardial infarction undergoing emergency PCI

Six groups based on eGFR strata (>90, 60–90, 30–60 mL/min/1.73m²), each divided into: SGLT2 inhibitor group (dapagliflozin 10 mg daily) Placebo group

Change in serum creatinine at 48–72 hours from baseline (pre-contrast) Occurrence of CI-AKI (increase in creatinine ≥0.3 mg/dL or ≥50% within 48–72 hours) Need for renal replacement therapy (dialysis) during follow-up Change in eGFR from baseline Hospital length of stay related to renal complications

In this study, patients will be randomly assigned to two intervention groups (SGLT2i recipients) and a control group in a 1:1 ratio. The randomization sequence will be generated using SPSS software. To maintain balance in the number of patients in each group, a block randomization method with variable block sizes will be used. The allocation sequence will be prepared and maintained by an independent person who is not involved in the study implementation process to prevent any bias in allocation.

Raw study data including demographic characteristics, baseline clinical and laboratory parameters, type and volume of contrast media, SGLT2 inhibitor use, and primary outcome data (serum creatinine changes and incidence of acute kidney injury). All data will be de-identified prior to sharing and will be made available in electronic format solely for research purposes upon reasonable request and approval by the ethics committee.

Data will be available starting 6 months after publication of the final study results and will remain accessible for a period of 5 years thereafter.

Researchers affiliated with recognized academic, scientific, or research institutions who submit a formal request with a relevant research proposal and obtain approval from the study ethics committee will be granted access to the data.

The data may be used solely for research purposes and for conducting secondary scientific analyses related to kidney injury and associated outcomes. Commercial use, re-identification of participants, or use beyond the approved research scope is not permitted. Access is subject to submission of a formal request, a clearly defined research proposal, a written commitment to data confidentiality, and approval by the study ethics committee.

Applicants seeking access to study data or documents should contact the Clinical Research Office of Shiraz University of Medical Sciences or the official email of the study data custodian, submitting their request along with a research proposal and a confidentiality agreement.

After submission of a formal request with a research proposal and confidentiality agreement, the request is reviewed by the data custodian. The study ethics committee then evaluates whether the proposed use aligns with research objectives and confidentiality requirements. Upon approval, access to the data or documents is granted in a de-identified format with data protection instructions.

All provided data and documents will be de-identified, with no personally identifiable information included. Use of the data is restricted to approved research purposes, and any sharing or publication to third parties without ethics committee approval is prohibited.