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OpenTrials
Completed

NCT Number: NCT03347032

Remote Ischemic Preconditioning for Renal Protection in TAVI

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Contrast-induced Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Valve Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

Serial inflations and deflations as detailed in the arm/group descriptions

Control

Procedure

Serial inflations and deflations as detailed in the arm/group descriptions

Primary outcomes

  1. Renal function as a measured by serum creatinine

    Time frame: 48-72 hours

    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.

Secondary outcomes

  1. Clinical Outcomes

    Time frame: 6 months

    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.

  2. Clinical Outcomes

    Time frame: 6 months

    The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2017
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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