SGLT2-inhibitors on PC-AKI

Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy

Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).

Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.

Study Overview

• Status: Active, not recruiting
• Conditions: Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy
• Intervention / Treatment: Drug: SGLT-2 inhibitors

• Study Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ACS patients aged 18-80 years old receiving invasive treatment were enrolled.

Description

Inclusion Criteria:

• ACS patients undergoing invasive treatment (PCI or CAG)
• 18 ~ 80 years old adult patients
• Written informed consent provided

Exclusion Criteria:

• Administration of any iodinated CM within 14 days before CAG or PCI
• Hepatic dysfunction (ALT 3 times greater than upper normal limit)
• Thyreoid insufficiency
• Renal artery Stenosis (unilateral >70％ or bilateral stenosis>50％)
• Known allergy to any of the study drugs or devices (iodinated CM, etc.)
• Pregnancy or lactation
• Contraindications for the use of SGLT-2 inhibitors, such as severe renal insufficiency (eGFR <30 mL/min/1.73m2 or currently on dialysis), type 1 diabetes mellitus, severe infection, etc.)
• Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving invasive treatment; Patients receiving PCI or CAG were enrolled to evaluate the impact of SGLT-2 inhibitors use or not use and duration of SGLT-2 inhibitors administration	Drug: SGLT-2 inhibitors; SGLT-2 inhibitors use or not use； the duration of SGLT-2 inhibitors use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post contrast acute kidney injury (PC-AKI)	PC-AKI was defined by the European Society of Genitourinary Radiology (EUSR): increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline	48 hours after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		up to 12 months
Major adverse cardiovascular and cerebrovascular events(MACCE)	Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization	up to 12 months

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Pharmacologic Actions; Chemical Actions and Uses; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: TIMING-AKI V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No