SGLT2-inhibitors on PC-AKI

Recruiting

• Conditions: Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy
• Interventions: Drug: SGLT-2 inhibitors

• Registration Number: NCT06491953
• Lead Sponsor: Shenyang Northern Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving invasive treatment	SGLT-2 inhibitors	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

Primary Outcome Measures

Name	Time	Method
Incidence of Post contrast acute kidney injury (PC-AKI)	48 hours after procedure	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China