Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury

Phase 4

Suspended

• Conditions: Acute Kidney Injury; Percutaneous Coronary Intervention
• Interventions: Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT05435235
• Lead Sponsor: Albert Einstein Healthcare Network

Brief Summary

To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Start: 2024-09-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age 18 years or more.
2. Scheduled/non-emergent Percutaneous coronary intervention (PCI).
3. Post-index procedure Staged PCI with at least 14 days from contrast exposure.
4. Patient can fully understand the study information and sign informed consent.

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Exclusion Criteria

1. Cardiogenic shock /need for inotrope or mechanical pump support.
2. Acute kidney injury as defined by KDIGO criteria (<4 weeks) prior to PCI.
3. End-Stage Renal Disease prior to PCI (On renal replacement therapy).
4. Diabetes Mellitus type 1.
5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose >400 mg/dl).
6. ST-segment elevation Myocardial Infarction undergoing index PCI.
7. Active Genitourinary infection.
8. Diagnostic Left Heart Catheterization without PCI.
9. Patients undergoing zero contrast PCI.
10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
12. Patients with Acute Heart Failure admission < 30 days prior to PCI.
13. Intercurrent illness resulting in volume depletion and hypotension (MAP<60 mmHg).
14. Patients with a kidney transplant.
15. Any contrast exposure within 14 days.
16. Patients with estimated glomerular filtration rate (eGFR) < 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
17. Patients with an active intrinsic inflammatory or autoimmune renal pathology.
18. Women of child bearing age (<50 years old).
19. Prison Inmates

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin arm	Dapagliflozin 10mg Tab	Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	Within 7 days.	According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: 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 which is known or presumed to have occurred within the prior 7 days.; We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	7 days	Days
Incidence of genitourinary infections	7 days	Symptomatic pyuria or new vaginal infection.

Trial Locations

Locations (1)

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States