About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Optimal medical therapy (OMT)
- Catheter-based angiography
- Measurement of translesional pressure gradients
- Renal artery stenting
- Sham (No Treatment)
Treatment groups
Sponsors and collaborators
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