Remote Ischemic Preconditioning for Renal Protection in TAVI

Henry Ford Health

Status: Completed

Conditions: Aortic Valve Stenosis; Renal Insufficiency; Contrast-induced Nephropathy

Treatments: Procedure: Control; Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03347032

RIPC TAVI

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning

Control

Sham Comparator group

Description:

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.

Treatment:

Procedure: Control