Remote Ischemic Preconditioning for Renal Protection in TAVI

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347032
• Other study ID #: RIPC TAVI
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Contrast-induced Nephropathy
• Renal Insufficiency

Intervention

Procedure:
• Remote ischemic preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions
• Control
Serial inflations and deflations as detailed in the arm/group descriptions

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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