Actively Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Led by University of Aarhus · Updated on 2026-04-23
80
Participants Needed
3
Research Sites
205 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One or more severe atherosclerotic renal artery stenoses defined as a stenosis 670% by catheter-based angiography.
- Presence of at least one high-risk clinical syndrome: resistant hypertension with average 24-hour ambulatory systolic blood pressure 6150 mmHg despite 653 antihypertensive drugs including a diuretic at optimal doses.
- Rapidly declining kidney function with estimated GFR reduction of more than 5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure 6140 mmHg despite 653 antihypertensive drugs including a diuretic at optimal doses.
- Hospital admissions with acute decompensated heart failure (at least 2 hospitalizations for heart failure or 1 hospitalization for sudden pulmonary edema) without obvious causes and average 24-hour ambulatory systolic blood pressure 6140 mmHg despite 653 antihypertensive drugs including a diuretic at optimal doses.
- All 24-hour ambulatory blood pressure monitorings to be performed after nurse-administered medication.
You will not qualify if you...
- Unable to provide informed consent.
- Treatment-resistant heart failure episodes presumed caused by renovascular disease.
- Rapidly declining kidney function or acute kidney failure near dialysis need presumed caused by renovascular disease.
- Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known prior to randomization.
- Pregnancy or unknown pregnancy status in females of childbearing potential.
- Kidney size less than 7 cm supplied by target vessel.
- Previous kidney transplant.
- Previous percutaneous transluminal renal angioplasty (PTRA) treatment.
- Presence of renal artery stenosis not suitable for stenting.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Odense University Hospital
Odense C, Denmark, 5000
Actively Recruiting
Research Team
S
Sebastian Nielsen, MD
CONTACT
M
Mark Reinhard, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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