Renovascular HypertensionDAN-PTRAIINCT05834803
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
A study testing Optimal medical therapy (OMT), Catheter-based angiography and Measurement of translesional pressure gradients in people with Renovascular Hypertension and Renovascular Hypertension With Renal Failure, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure
- What is being tested?
- Optimal medical therapy (OMT), Catheter-based angiography and Measurement of translesional pressure gradients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- 26 Jun 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 hospitalization 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 measurements are performed after nurse-administered medication.
Who cannot join
- 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.
Show all 18Show fewer
- Previous kidney transplant.
- Previous PTRA with stent placement.
- Presence of a renal artery stenosis not amenable for treatment with a stent.
- Intolerance to any antithrombotic treatment.
- 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 mmHg, or
- a systolic translesional gradient of ≥20 mmHg, or
- a renal fractional flow reserve (Pd/Pa) of ≤0.80
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Sebastian Nielsen, MD, sebane@rm.dk
Mark Reinhard, MD, PhD, markrein@rm.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Jonas P Eiberg, MD, PhD, jonas.peter.eiberg@regionh.dk
- Recruiting
Odense University Hospital
Odense C, 5000
Michael D Schultz, MD, michael.dyrehauge.schultz@rsyd.dk
About this study
Official title: Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.
The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. The main questions the trial aims to answer are whether renal artery stenting in addition to optimal medical therapy, compared with a sham procedure and optimal medical therapy, has beneficial effects on:
- Blood pressure (primary outcome: 24-hour ambulatory systolic blood pressure at 6 months)
- Kidney function
- Hospitalizations for heart failure
Read the detailed description
Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRAI study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting.
The DAN-PTRAII study is a nationwide randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and the interventional team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with a sham procedure, both in addition to optimal medical therapy, on blood pressure, kidney function, and hospitalizations for heart failure.
- Conditions
- Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic
- Being tested
- Optimal medical therapy (OMT), Catheter-based angiography, Measurement of translesional pressure gradients, Renal artery stenting, Sham (No Treatment)
- Keywords
- percutaneous transluminal angioplasty, renal artery stenosis, renal artery stenting, sham-controlled, renovascular disease
- Medical subject headings
- Hypertension, Renovascular, Heart Failure, Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal medical therapy (OMT)Drug
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 angiographyDiagnostic test
Catheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradientsDiagnostic test
Measurement of translesional pressure gradients performed in accordance with the study protocol.
Renal artery stentingProcedure or surgery
Renal artery stenting performed in accordance with the study protocol.
Sham (No Treatment)Procedure or surgery
Sham procedure performed in accordance with the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Renal artery stenting | Experimental | Percutaneous transluminal renal angioplasty with stent placement Receives: Drug: Optimal medical therapy (OMT); Diagnostic Test: Catheter-based angiography; Diagnostic Test: Measurement of translesional pressure gradients; Procedure: Renal artery stenting |
| Sham procedure | Sham comparator | Sham procedure Receives: Drug: Optimal medical therapy (OMT); Diagnostic Test: Catheter-based angiography; Diagnostic Test: Measurement of translesional pressure gradients; Procedure: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour ambulatory systolic blood pressure
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 6 months.
Measured: Baseline and 6 months
Secondary outcomes (20)
Change in estimated glomerular filtration rate (eGFR)
Defined as the between-group difference in the change in estimated glomerular filtration rate (eGFR) from baseline to 6 months.
Measured: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months
Change in urine albumin-to-creatinine ratio (UACR)
Defined as the between-group difference in the change in urine albumin-to-creatinine ratio from baseline to 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Change in attended automated office systolic blood pressure
Defined as the between-group difference in the change in attended automated office systolic blood pressure from baseline to 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Change in unattended automated office systolic blood pressure
Defined as the between-group difference in the change in unattended automated office systolic blood pressure from baseline to 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Change in defined daily dose (DDD) of antihypertensive medications
Defined as the between-group difference in the change in defined daily dose (DDD) of antihypertensive medications from baseline to 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Change in the number of antihypertensive medications
Defined as the between-group difference in the change in the number of antihypertensive medications from baseline to 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Change in 24-hour ambulatory systolic blood pressure (corrected for changes in antihypertensive medication)
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 3 and 6 months, corrected for changes in antihypertensive medication burden (1 DDD = 5 mmHg).
Measured: Baseline, 3 months, and 6 months
Number of participants with cardiovascular or kidney outcomes
Between-group comparison of the number of participants with clinical events from baseline to 6 months.
Clinical events are defined using the same criteria as in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, except for progressive renal insufficiency (defined in CORAL as a reduction from baseline of 30% or more in estimated GFR).
Clinical events included in the composite endpoint from baseline to 6-month follow-up are:
- Death from cardiovascular causes
- Death from renal causes
- Stroke
- Myocardial infarction
- Hospitalization for congestive heart failure
- Progressive renal insufficiency (a reduction from baseline of 50% or more in estimated GFR)
- Permanent renal-replacement therapy
Only the first event per participant is included in the composite.
Measured: From baseline to 6 months
Number of deaths from any cause
Between-group comparison of the number of participants with death from any cause from baseline to 6 months.
Measured: From baseline to 6 months
Change in health status on 12-item Short Form Health Survey (SF-12)
Defined as the between-group difference in the change in 12-item Short Form Health Survey (SF-12) scores from baseline to 3 and 6 months.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Baseline, 3 months, and 6 months
Number of serious adverse events (SAEs) during follow-up and procedure-related and postoperative adverse events within 30 days after the procedure
All SAEs occurring from baseline to 6 months, as well as procedure-related adverse events (≤24 hours) and postoperative adverse events (>24 hours) occurring within 30 days after the procedure, will be systematically recorded. Events include, but are not limited to:
- Death from any cause
- Rupture, dissection, occlusion, or perforation of the renal artery
- Stent thrombosis of the PTRA-treated renal artery
- Embolic complications affecting the kidney or peripheral circulation (upper or lower extremity depending on access site)
- Bleeding requiring transfusion
- Embolization or nephrectomy due to bleeding or other complications
- Access-related complications requiring treatment: bleeding, thrombosis, or pseudoaneurysm
- Need for acute dialysis
- Clinical events as defined above
Measured: From baseline to 6 months (SAEs); from baseline to 30 days (procedure-related and postoperative adverse events)
Change in intrarenal resistive index
Defined as the between-group difference in the change in intrarenal resistive index (unitless) of the affected kidney from baseline to 6 months, measured by Doppler ultrasound.
Additional renal ultrasound and Doppler parameters (kidney length, peak systolic velocity, acceleration time, renal-renal ratio, and pulsatility index) will be assessed at baseline and 6 months and compared between groups. In exploratory analyses, the association between baseline intrarenal resistive index (≥0.80 vs <0.80) and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated, and the diagnostic accuracy (sensitivity and specificity) of baseline Doppler ultrasound for identifying hemodynamically significant renal artery stenosis will be assessed using invasive pressure measurement as the reference standard.
Measured: Baseline and 6 months
Change in left ventricular mass index
Defined as the between-group difference in the change in left ventricular mass index (g/m²) from baseline to 6 months, assessed by transthoracic echocardiography.
Additional transthoracic echocardiographic parameters of cardiac systolic and diastolic function and cardiac chamber dimensions and volumes will be assessed at baseline and 6 months and compared between groups.
Measured: Baseline and 6 months
Change in split renal function of the affected kidney
Defined as the between-group difference in the change in split renal function (%) of the affected kidney from baseline to 6 months, assessed by renography.
The change in renogram configuration (renogram grade) of the affected kidney from baseline to 6 months will be compared between groups as the proportion of participants with improvement in renogram grade. In exploratory analyses, the diagnostic accuracy (sensitivity and specificity) of baseline renography for identifying hemodynamically significant renal artery stenosis will be assessed using invasive pressure measurement as the reference standard, and the association between baseline renography with intermediate/high probability of renovascular hypertension and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Measured: Baseline and 6 months
Translesional pressure ratio (Pd/Pa) across renal artery stenoses
Defined as the distal-to-aortic pressure ratio (Pd/Pa, unitless) across the target renal artery stenosis, measured by intra-arterial pressure assessment during the endovascular procedure.
Systolic, diastolic, mean, and pulse pressure gradients (mmHg) across the target renal artery stenosis will be measured invasively during the procedure. In exploratory analyses, the association between baseline Pd/Pa and mean and systolic translesional pressure gradients and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated, and whether the effect of PTRA differs according to baseline Pd/Pa will be explored.
Measured: Baseline and 6 months
Agreement between CFD-derived and invasively measured translesional pressure ratio (Pd/Pa)
Defined as the mean difference (Bland-Altman bias, unitless) between Pd/Pa derived non-invasively from CT angiography using computational fluid dynamics (CFD) and Pd/Pa measured invasively during the endovascular procedure.
Agreement between CFD-derived and invasively measured mean and systolic translesional pressure gradients will be assessed correspondingly. In exploratory analyses, the association between CFD-derived Pd/Pa and mean and systolic translesional pressure gradients and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Measured: Baseline and 6 months
Change in plasma renin
Defined as the between-group difference in the change in plasma renin concentration (mIU/L) from baseline to 3 and 6 months.
In exploratory analyses, the association between baseline plasma renin and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Measured: Baseline, 3 months, and 6 months
Change in plasma aldosterone
Defined as the between-group difference in the change in plasma aldosterone concentration (pmol/L) from baseline to 3 and 6 months.
In exploratory analyses, the association between baseline plasma aldosterone and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Measured: Baseline, 3 months, and 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Defined as the between-group difference in the change in plasma NT-proBNP concentration (ng/L) from baseline to 3 and 6 months.
In exploratory analyses, the association between changes in echocardiographic parameters, including left ventricular mass index, and the change in NT-proBNP from baseline to 6 months will be evaluated to assess whether changes in NT-proBNP reflect changes in cardiac structure and function.
Measured: Baseline, 3 months, and 6 months
Proteomic profile in blood and on the angioplasty balloon
Defined as the proteomic profile in blood and in material retrieved from the angioplasty balloon after dilation during PTRA. In exploratory analyses, the association between the proteomic profile and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months, and the need for reintervention due to restenosis, will be evaluated. Proteomic analyses will be described in a separate analysis plan.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start26 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renovascular HypertensionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Danish Nationwide (3-center) Randomized and Sham-Controlled Study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Gødstrup Hospital, Holbaek Sygehus, Amsterdam UMC, The Augustinus Foundation, Denmark., Novo Nordisk Foundation
- Responsible party
- Sponsor
- Investigators
- Mark Reinhard, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834803
- Sponsor's protocol ID
- DAN-PTRAII
- Acronym
- DAN-PTRAII
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinhard M, Schousboe K, Andersen UB, Buus NH, Rantanen JM, Bech JN, Mafi HM, Langfeldt S, Bharadwaz A, Horlyck A, Jensen MK, Jeppesen J, Olsen MH, Jacobsen IA, Bibby BM, Christensen KL. Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study. J Am Heart Assoc. 2022 Apr 5;11(7):e024421. doi: 10.1161/JAHA.121.024421. Epub 2022 Mar 24.
PubMed 35322677
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.
- ClinicalTrials.gov ID
- NCT05834803
- Acronym / sponsor ID
- DAN-PTRAII / DAN-PTRAII
- Conditions
- Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic
- Keywords
- percutaneous transluminal angioplasty, renal artery stenosis, renal artery stenting, sham-controlled, renovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Gødstrup Hospital, Holbaek Sygehus, Amsterdam UMC, The Augustinus Foundation, Denmark., Novo Nordisk Foundation
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. The main questions the trial aims to answer are whether renal artery stenting in addition to optimal medical therapy, compared with a sham procedure and optimal medical therapy, has beneficial effects on:
- Blood pressure (primary outcome: 24-hour ambulatory systolic blood pressure at 6 months)
- Kidney function
- Hospitalizations for heart failure
Detailed description
Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRAI study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting.
The DAN-PTRAII study is a nationwide randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and the interventional team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with a sham procedure, both in addition to optimal medical therapy, on blood pressure, kidney function, and hospitalizations for heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Danish Nationwide (3-center) Randomized and Sham-Controlled Study.
| Arm | Type | Receives |
|---|---|---|
| Renal artery stenting | Experimental | Drug: Optimal medical therapy (OMT), Diagnostic Test: Catheter-based angiography, Diagnostic Test: Measurement of translesional pressure gradients, Procedure: Renal artery stentingPercutaneous transluminal renal angioplasty with stent placement |
| Sham procedure | Sham comparator | Drug: Optimal medical therapy (OMT), Diagnostic Test: Catheter-based angiography, Diagnostic Test: Measurement of translesional pressure gradients, Procedure: Sham (No Treatment)Sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- All 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Renal artery stenting, Sham procedure |
| Catheter-based angiographyCatheter-based angiography performed in accordance with the study protocol. | Diagnostic test | Renal artery stenting, Sham procedure |
| Measurement of translesional pressure gradientsMeasurement of translesional pressure gradients performed in accordance with the study protocol. | Diagnostic test | Renal artery stenting, Sham procedure |
| Renal artery stentingRenal artery stenting performed in accordance with the study protocol. | Procedure or surgery | Renal artery stenting |
| Sham (No Treatment)Sham procedure performed in accordance with the study protocol. | Procedure or surgery | Sham procedure |
Primary outcome
Change in 24-hour ambulatory systolic blood pressure
Time frame: 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.
20 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months
Change in urine albumin-to-creatinine ratio (UACR)
Time frame: Baseline, 3 months, and 6 months
Change in attended automated office systolic blood pressure
Time frame: Baseline, 3 months, and 6 months
Change in unattended automated office systolic blood pressure
Time frame: Baseline, 3 months, and 6 months
Change in defined daily dose (DDD) of antihypertensive medications
Time frame: Baseline, 3 months, and 6 months
Change in the number of antihypertensive medications
Time frame: Baseline, 3 months, and 6 months
Change in 24-hour ambulatory systolic blood pressure (corrected for changes in antihypertensive medication)
Time frame: Baseline, 3 months, and 6 months
Number of participants with cardiovascular or kidney outcomes
Time frame: From baseline to 6 months
Number of deaths from any cause
Time frame: From baseline to 6 months
Change in health status on 12-item Short Form Health Survey (SF-12)
Time frame: Baseline, 3 months, and 6 months
Number of serious adverse events (SAEs) during follow-up and procedure-related and postoperative adverse events within 30 days after the procedure
Time frame: From baseline to 6 months (SAEs); from baseline to 30 days (procedure-related and postoperative adverse events)
Change in intrarenal resistive index
Time frame: Baseline and 6 months
Change in left ventricular mass index
Time frame: Baseline and 6 months
Change in split renal function of the affected kidney
Time frame: Baseline and 6 months
Translesional pressure ratio (Pd/Pa) across renal artery stenoses
Time frame: Baseline and 6 months
Agreement between CFD-derived and invasively measured translesional pressure ratio (Pd/Pa)
Time frame: Baseline and 6 months
Change in plasma renin
Time frame: Baseline, 3 months, and 6 months
Change in plasma aldosterone
Time frame: Baseline, 3 months, and 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, 3 months, and 6 months
Proteomic profile in blood and on the angioplasty balloon
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 35322677Reinhard M, Schousboe K, Andersen UB, Buus NH, Rantanen JM, Bech JN, Mafi HM, Langfeldt S, Bharadwaz A, Horlyck A, Jensen MK, Jeppesen J, Olsen MH, Jacobsen IA, Bibby BM, Christensen KL. Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study. J Am Heart Assoc. 2022 Apr 5;11(7):e024421. doi: 10.1161/JAHA.121.024421. Epub 2022 Mar 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Reinhard, MD, PhD principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal medical therapy (OMT), Catheter-based angiography and Measurement of translesional pressure gradients in people with Renovascular Hypertension and Renovascular Hypertension With Renal Failure, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Nielsen, MD (+45 23100484, sebane@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour ambulatory systolic blood pressure (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.