Functional Renal Hemodynamics in Patients with Renal Artery Stenosis 3
- Conditions
- Renal artery stenosis
- Registration Number
- NL-OMON27493
- Lead Sponsor
- Dutch Kidney Foundation, Philips N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Age > 18
-Written informed consent
-Clinical indication for percutaneous transluminal renal angioplasty
-Clinically and hemodynamically stable
-CT-angiogram or MR-angiogram of the renal arteries
-Available or scheduled renography
-Known atrial fibrillation with irregular ventricular response rate
-Increased risk for contrast nephropathy defined as presence of renal impairment (eGFR <30ml/min) according to the Guideline Safe Use of Contrast Media of the Radiology Society of the Netherlands (November 2017)
-Women of child bearing age not on active birth control
-Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Receiver operating characteristics for predicting ambulatory blood pressure response after renal angioplasty by (1) the hyperemic pressure gradient and (2) the hyperemic pressure gradient and the renal flow reserve.
- Secondary Outcome Measures
Name Time Method Intra-class correlation and level and limits of agreement (Bland-Altman plot) between the CFD-predicted and the invasively measured mean translesional hyperemic pressure gradient (MHG) of a renal artery stenosis. <br>Renal function response after renal angioplasty and an exploratory analysis of the predictive power for renal function improvement and blood pressure response by the hyperemic pressure gradient, the renal flow reserve and related hemodynamic parameters.