Remote Ischemic Preconditioning for Renal Protection in TAVI

Study Overview
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Brief Summary
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Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.

Official Title
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Remote Ischemic Preconditioning for Renal Protection in Patients Undergoing Transcatheter Aortic Valve Interventions

Conditions
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Aortic Valve Stenosis, Renal Insufficiency, Contrast-induced Nephropathy

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention Exclusion Criteria: Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes Systemic hypotension (systolic blood pressure < 90mmHg) Patients currently on hemodialysis Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm Patients enrolled in other active cardiovascular investigational studies Severe comorbidities with a life expectancy of less than 6 months Pregnant or lactating women Patients unable to provide consent Patients taking the medication glibenclamide for treatment of diabetes

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles. | Procedure: Remote ischemic preconditioning<br>* Serial inflations and deflations as detailed in the arm/group descriptions<br>|
| Sham Comparator: Control<br>This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles. | Procedure: Control<br>* Serial inflations and deflations as detailed in the arm/group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function as a measured by serum creatinine | Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study. | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes | The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason. | 6 months | 
| Clinical Outcomes | The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission | 6 months |