SGLT2-inhibitors on PC-AKI

NCT06491953 | Active Not Recruiting DMC

• 1 other identifier: TIMING-AKI V1.0
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Major adverse cardiovascular and cerebrovascular events(MACCE)

  up to 12 months

• All-cause mortality

  up to 12 months

Study Arms (1)

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

Interventions

SGLT-2 inhibitors DRUG

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

Patients receiving invasive treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)