Remote Ischemic Preconditioning for Renal Protection in TAVI

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency; Aortic Valve Stenosis; Contrast-induced Nephropathy
• Intervention / Treatment: Procedure: Remote ischemic preconditioning; Procedure: Control

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Serial inflations and deflations as detailed in the arm/group descriptions
Sham Comparator: Control; 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; Serial inflations and deflations as detailed in the arm/group descriptions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: William O'Neill, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Renal Insufficiency
• Other Study ID Numbers: RIPC TAVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No