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Functional Renal Hemodynamics in Patients with Renal Artery Stenosis 3

Functional Renal Hemodynamics in Patients with Renal Artery Stenosis 3

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27493
Enrollment
30
Registered
2020-02-24
Start date
2020-01-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal artery stenosis

Interventions

None

Sponsors

Dutch Kidney Foundation, Philips N.V.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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.

Contacts

Public ContactLennart van de Velde

Amsterdam UMC, location AMC

l.vandevelde@amsterdamumc.nl020 56 68791

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)