Skip to content

SGLT2-inhibitors on PC-AKI

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06491953
Enrollment
3600
Registered
2024-07-09
Start date
2024-06-01
Completion date
2026-05-28
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy

Brief summary

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.

Interventions

SGLT-2 inhibitors use or not use; the duration of SGLT-2 inhibitors use

Sponsors

Shenyang Northern Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post contrast acute kidney injury (PC-AKI)48 hours after procedurePC-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

Secondary

MeasureTime frameDescription
Major adverse cardiovascular and cerebrovascular events(MACCE)up to 12 monthsCardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization
All-cause mortalityup to 12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026