SGLT2-inhibitors on PC-AKI

Shenyang Northern Hospital

Status: Active, not recruiting

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

Treatments: Drug: SGLT-2 inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT06491953

TIMING-AKI V1.0

Details and patient eligibility

About

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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,600 participants in 1 patient group

Patients receiving invasive treatment

Description:

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

Treatment:

Drug: SGLT-2 inhibitors