Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty
In brief
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
Key facts
- Study ID
- NCT05834803
- Run by
- University of Aarhus
- People needed
- 80
- Starts
- 2023-06-26
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
- In addition, at least one of the following high-risk clinical syndromes:
- 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.
- All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.
You may not qualify if…
- 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.
- Pregnancy or unknown pregnancy status in female of childbearing potential.
- Kidney size <7 cm (pole to pole length) supplied by target vessel.
- Previous kidney transplant.
- Previous PTRA treatment.
- Presence of a renal artery stenosis not amenable for treatment with a stent.
- Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.
- Patients treated with renal artery stenting without randomization in the study period include patients with:
- 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.
- At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:
- a mean translesional gradient of ≥10 mm Hg, or
- a systolic translesional gradient of ≥20 mm Hg, or
- a renal fractional flow reserve (Pd/Pa) of ≤0.8
Where it is running
- Aarhus University Hospital — Aarhus N, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Odense University Hospital — Odense C, Denmark (enrolling)
Full record on ClinicalTrials.gov
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