Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
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
ClinicalTrials.gov IDNCT05834803
PhaseNA
Enrollment80
SponsorUniversity of Aarhus
Age18 Years
SexALL
Conditions studied
Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty
About this study
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
Interventions
- Drug: Optimal medical therapy (OMT) — Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
- Diagnostic Test: Catheter-based angiography — Catheter-based angiography performed in accordance with the study protocol.
- Diagnostic Test: Measurement of translesional pressure gradients — Measurement of translesional pressure gradients performed in accordance with the study protocol.
- Procedure: Renal artery stenting — Renal artery stenting performed in accordance with the study protocol.
- Procedure: Sham (No Treatment) — Sham procedure performed in accordance with the study protocol.
Primary outcomes
- Change in 24-hour ambulatory systolic blood pressure (Baseline and 6 months)
Eligibility information
Inclusion Criteria:
1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
2. In addition, at least one of the following high-risk clinical syndromes:
1. 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.
2. 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.
3. 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.
Exclusion Criteria:
* 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:
1. Treatment-resistant heart failure episodes presumed caused by renovascular disease.
2. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
3. 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
Study locations
- Aarhus University Hospital, Aarhus N, 8200 Denmark
- Rigshospitalet, Copenhagen, 2100 Denmark
- Odense University Hospital, Odense C, 5000 Denmark
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.