Status:
SUSPENDED
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury
Lead Sponsor:
Albert Einstein Healthcare Network
Conditions:
Acute Kidney Injury
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Age 18 years or more.
- Scheduled/non-emergent Percutaneous coronary intervention (PCI).
- Post-index procedure Staged PCI with at least 14 days from contrast exposure.
- Patient can fully understand the study information and sign informed consent.
Exclusion
- Cardiogenic shock /need for inotrope or mechanical pump support.
- Acute kidney injury as defined by KDIGO criteria (\<4 weeks) prior to PCI.
- End-Stage Renal Disease prior to PCI (On renal replacement therapy).
- Diabetes Mellitus type 1.
- Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \>400 mg/dl).
- ST-segment elevation Myocardial Infarction undergoing index PCI.
- Active Genitourinary infection.
- Diagnostic Left Heart Catheterization without PCI.
- Patients undergoing zero contrast PCI.
- Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
- Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
- Patients with Acute Heart Failure admission \< 30 days prior to PCI.
- Intercurrent illness resulting in volume depletion and hypotension (MAP\<60 mmHg).
- Patients with a kidney transplant.
- Any contrast exposure within 14 days.
- Patients with estimated glomerular filtration rate (eGFR) \< 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
- Patients with an active intrinsic inflammatory or autoimmune renal pathology.
- Women of child bearing age (\<50 years old).
- Prison Inmates
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05435235
Start Date
September 1 2024
End Date
June 1 2025
Last Update
July 31 2024
Active Locations (1)
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1
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141