SGLT2-inhibitors on PC-AKI | NCT06491953

Studies
SGLT2-inhibitors on PC-AKI

NCT06491953

Sponsor

Shenyang Northern Hospital

Status

Active, not recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

3,600Estimated

Phase

Not provided

Conditions

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

Interventions

SGLT-2 inhibitors

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

May 30, 2025Actual

Completion Date

May 28, 2026Estimated

First Submitted Date

Jul 1, 2024

First Submission Date that Met QC Criteria

Jul 8, 2024

First Posted Date

Jul 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2025

Last Update Posted Date

Sep 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SGLT-2 inhibitors	Drug	SGLT-2 inhibitors use or not use； the duration of SGLT-2 inhibitors use	Patients receiving invasive treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Northern Theater Command		Shenyang	Liaoning		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

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Browse Branches

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