SGLT2-inhibitors on PC-AKI

NCT ID: NCT06491953

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-05-28

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

SGLT-2 inhibitors

Intervention Type: DRUG

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

Interventions

SGLT-2 inhibitors

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Countries

China

Other Identifiers

TIMING-AKI V1.0

Identifier Type: -

Identifier Source: org_study_id