The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on:
* Blood pressure * Kidney function * Hospitalizations for heart failure
One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
Rapidly declining kidney function with a reduction in estimated GFR of >5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction <40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
Unable to provide informed consent.
Treatment-resistant heart failure episodes presumed caused by renovascular disease.
Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
Parallel
Optimal medical therapy (OMT)
DrugOptimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
Catheter-based angiography
Diagnostic testCatheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradients
Diagnostic testMeasurement of translesional pressure gradients performed in accordance with the study protocol.
Renal artery stenting
Procedure/SurgeryRenal artery stenting performed in accordance with the study protocol.
Sham (No Treatment)
Procedure/SurgerySham procedure performed in accordance with the study protocol.
Change in 24-hour ambulatory systolic blood pressure
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 6 months.
Change in estimated glomerular filtration rate (eGFR)
Defined as the between-group difference in the change in estimated glomerular filtration rate (eGFR) from baseline to 6 months.
Change in attended automated office systolic blood pressure
Defined as the between-group difference in the change in attended automated office systolic blood pressure from baseline to 6 months.
Change in unattended automated office systolic blood pressure
Defined as the between-group difference in the change in unattended automated office systolic blood pressure from baseline to 6 months.
Change in defined daily dose (DDD) of antihypertensive medications
Defined as the between-group difference in the change in defined daily dose (DDD) of antihypertensive medications from baseline to 6 months.
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Gødstrup Hospital
Collaborator
Holbaek Sygehus
Collaborator
Amsterdam UMC
Collaborator
The Novo Nordic Foundation
Collaborator
The Augustinus Foundation, Denmark.
Collaborator
