NCT03347032

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

November 8, 2017

Last Update Submit

December 12, 2022

Conditions

Aortic Valve StenosisRenal InsufficiencyContrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Clinical Outcomes

    6 months

  • Clinical Outcomes

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Remote ischemic preconditioningPROCEDURE

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

Intervention
ControlPROCEDURE

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Aortic Valve StenosisRenal Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • William O'Neill, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 20, 2017

Study Start

February 13, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

US(1)