Could stenting kidney arteries lower blood pressure and protect kidneys?
NCT ID NCT05834803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a procedure to open narrowed kidney arteries (renal artery stenting) helps high-risk patients with resistant high blood pressure, declining kidney function, or heart failure. About 80 participants will either receive the real procedure or a sham procedure, and all will continue optimal medical therapy. Researchers will measure changes in blood pressure and kidney function after 6 months to see if stenting provides added benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital
RECRUITINGAarhus N, 8200, Denmark
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Odense University Hospital
RECRUITINGOdense C, 5000, Denmark
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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