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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 standard of care.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Treatments: Dapagliflozin

Criteria

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 30 days from contrast exposure.

4. Patient is able to fully understand study information and sign informed consent.

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 >300 mg/dl).

6. ST-segment elevation Myocardial Infarction undergoing index PCI.

7. Active Genitourinary infection.

8. Diagnostic Left Heart Catheterization without PCI.

9. Patient's 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 hemodynamical 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<65 mmHg).

14. Patients with a kidney transplant.

15. Any contrast exposure within 30 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 renal pathology.

18. Pregnancy.

19. Prison Inmates