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IRCT20251230068494N1 IRCT 2026-05-05 Shiraz University of Medical Sciences Effect of SGLT2 Inhibitors in Preventing Kidney Failure After Angiography SPARK Investigating the effect of adding sglt2i in preventing kidney failure in patients receiving contrast in coronary angiography -Interventional - Randomized controlled clinical trial 2026-02-20 anticipated 150 Recruiting https://irct.ir/trial/88942 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 Kidney failure. Intervention 1: Intervention group (SGLT2 inhibitor): In addition to standard care, patients receive empagliflozin 10 mg orally once daily, starting 24 hours before angiography and continuing for 72 hours after angiography. Intervention 2: Control group (Placebo): In addition to standard care, patients receive a matching placebo orally once daily, starting 24 hours before angiography and continuing for 72 hours after angiography. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments: 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.
public Peyman Izadpanah
Shiraz Medical School, Imam Hossein Square, Zand Street, Shiraz, Iran
shiraz Iran (Islamic Republic of) 7134845794 +98 71 3233 5849 Paymanizadpanah@gmail.com Shiraz University of Medical Sciences scientific Peyman Izadpanah
Shiraz Medical School, Imam Hossein Square, Zand Street, Shiraz, Iran
shiraz Iran (Islamic Republic of) 7134845794 +98 71 3233 5849 Paymanizadpanah@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older .Scheduled for coronary angiography (elective or emergency) using iodinated contrast. Have normal renal parameters (eGFR ≥ 60 mL/min/1.73m²) or history of chronic kidney disease with eGFR ≤ 30 mL/min/1.73m². 18 years no limit Both Patients with known chronic kidney disease Baseline creatinine greater than 1.5 mg/dL Significant hypotension Anemia Patients with acute myocardial infarction undergoing emergency PCI I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery Treatment - Drugs Placebo Intervention group (SGLT2 inhibitor): In addition to standard care, patients receive empagliflozin 10 mg orally once daily, starting 24 hours before angiography and continuing for 72 hours after angiography. Control group (Placebo): In addition to standard care, patients receive a matching placebo orally once daily, starting 24 hours before angiography and continuing for 72 hours after angiography. Incidence of contrast-induced acute kidney injury (CI-AKI), defined as an increase in serum creatinine ≥0.3 mg/dL or ≥50% from baseline within 48–72 hours after angiography. Timepoint: Patients in both groups will be hospitalized for at least 72 hours after angiography to perform clinical and laboratory assessments (creatinine, eGFR, and metabolic parameters). Method of measurement: Serum Creatinine: Within the normal range of the reference laboratoryeGFR (Estimated Glomerular Filtration Rate): ≥ 60 mL/min/1.73m²BUN (Blood Urea Nitrogen): Within the normal rangeOther parameters related to kidney function (Na, K, etc.) are also recorded and examined quantitatively. Shiraz University of Medical Sciences Approved 2025-11-29 Ethics committee of Shiraz University of Medical Sciences Shiraz Medical School, Imam Hossein Square, Zand Street, Shiraz, Iran shiraz Fars Iran (Islamic Republic of)