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

Study Overview
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Brief Summary
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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.

Official Title
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Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury

Conditions
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Acute Kidney Injury, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Dapagliflozin 10mg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin arm<br>Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI. | Drug: Dapagliflozin 10mg Tab<br>* One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.<br>|
| No Intervention: Standard of care<br>Patients who received the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | 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. | Within 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Days | 7 days | 
| Incidence of genitourinary infections | Symptomatic pyuria or new vaginal infection. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography