Recruiting
Not applicable
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Condition(s) studied
Renovascular HypertensionRenovascular Hypertension With Renal FailureHeart FailureRenal Artery Stenosis AtheroscleroticPercutaneous Transluminal Angioplasty
Investigational drug(s) / intervention(s)
Optimal medical therapy (OMT)Catheter-based angiographyMeasurement of translesional pressure gradientsRenal artery stentingSham (No Treatment)
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.
Catheter-based angiography: Catheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradients: Measurement of translesional pressure gradients performed in accordance with the study protocol.
Renal artery stenting: Renal artery stenting performed in accordance with the study protocol.
Sham (No Treatment): Sham procedure performed in accordance with the study protocol.
Study summary
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
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
Primary outcome measure(s)
- Change in 24-hour ambulatory systolic blood pressure — Baseline and 6 months
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 6 months.
Trial sites (3)
| Facility | City | Region | Status |
| Aarhus University Hospital |
Aarhus N |
Denmark |
Recruiting |
| Rigshospitalet |
Copenhagen |
Denmark |
Recruiting |
| Odense University Hospital |
Odense C |
Denmark |
Recruiting |
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