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Clinical Trials/NCT05225077
NCT05225077
Unknown
Phase 4

Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease

Dong-A University1 site in 1 country600 target enrollmentJanuary 1, 2022

Overview

Phase
Phase 4
Intervention
Dapagliflozin 10 MG [Farxiga]
Conditions
Renal Insufficiency, Chronic
Sponsor
Dong-A University
Enrollment
600
Locations
1
Primary Endpoint
Incidence of contrast induced nephropathy
Last Updated
4 years ago

Overview

Brief Summary

This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moo Hyun Kim

Professor

Dong-A University

Eligibility Criteria

Inclusion Criteria

  • Age\>18 years
  • Written informed consent
  • Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 \[CKD stage G1-G3\]
  • Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients

Exclusion Criteria

  • Active malignancy
  • Class I or equivalent indication for treatment with a SGLT2 inhibitor
  • Pregnancy or willing of pregnancy during the follow up period
  • Active urogenital infection
  • Diabetes mellitus type 1
  • History of diabetic ketoacidosis
  • Cardiogenic shock
  • eGFR \< 29 ml/min/1.73m2

Arms & Interventions

Dapagliflozin 10mg group

Dapagliflozin 10 mg once a day for 1 month after the procedure.

Intervention: Dapagliflozin 10 MG [Farxiga]

Outcomes

Primary Outcomes

Incidence of contrast induced nephropathy

Time Frame: 48 hours

Serum creatinine (Scr) elevation of \>25% or \>0.5 mg/dl (44 μmol/l) from baseline within 48 hours

Study Sites (1)

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