Combined pressure-flow measurements under hyperaemia can identify those patients with renal artery stenosis that will benefit from renal revascularization, assessed by blood pressure and renal function. The hemodynamical significance of a renal…
Bron
Verkorte titel
Aandoening
Renal artery stenosis
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
In patients with renal artery stenosis (RAS), pressure and flow measurements in the renal artery may help identify patients who will benefit from percutaneous transluminal renal angioplasty (PTRA). Based on the findings of the first HERA study and the ongoing HERA-2 study, pressure and flow measurements under dopamine infusion in the renal artery are feasible, safe and reproducible. Moreover, image-based computational fluid dynamics (CFD) using CT angiography may be able to non-invasively reproduce these pressure measurements, which can strongly increase the clinical applicability of functional assessment in this disease. This study will assess the clinical value of pressure and flow assessment for predicting treatment response to PTRA and aim to validate the non-invasive pressure gradient assessment by CFD in patients with RAS.
Doel van het onderzoek
Combined pressure-flow measurements under hyperaemia can identify those patients with renal artery stenosis that will benefit from renal revascularization, assessed by blood pressure and renal function. The hemodynamical significance of a renal artery stenosis can be assessed non-invasively with CT-based computational fluid dynamics.
Onderzoeksopzet
Baseline blood pressure and renal function measurement, measurements during percutaneous transluminal angioplasty, 3-month follow-up measurements of blood pressure and renal function response.
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL8408 |
Ander register | METC AMC : METC2019_187 |