Renal Artery ObstructionDAN-PTRANCT02770066
A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
An observational study of Renal Artery Obstruction and Hypertension, Renovascular, run by University of Aarhus at 5 sites in Denmark.
Trial summary
A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Artery Obstruction, Hypertension, Renovascular, Cardiovascular Diseases
- What is being tested?
- Percutaneous transluminal renal angioplasty
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Jan 2015to Jan 2035
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: High-risk patients with renal artery stenosis
Who may be able to join
- All of the following:
- At least one of the above eligibility criteria
- Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis
- CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection
Who cannot join
- If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA
- PTRA of a renal artery supplying a kidney which pre-PTRA handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size < 7 cm (length)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Niels Henrik Buus, MD, DMSc, +45 9766 3725, n.buus@rn.dk
Niels Henrik Buus, MD, DMSc
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Mark Reinhard, MD, PhD, +45 4046 0321, m.reinhard@dadlnet.dk
Kent L Christensen, MD, DMSc, +45 7845 2455, klc@dadlnet.dk
- Recruiting
Glostrup University Hospital/ Rigshospitalet
Glostrup Municipality, 2600
Ulrik B Andersen, MD, +45 3863 3863, ulrik.bjoern.andersen@regionh.dk
Jørgen Jeppesen, MD, DMSc, +45 3863 3863, Joergen.Jeppesen.01@regionh.dk
- Recruiting
Holbaek Hospital
Holbæk, 4300
Michael H Olsen, MD, DMSc, michael.olsen@dadlnet.dk
Michael H Olsen, MD, DMSc
- Recruiting
Odense University Hospital
Odense C, 5000
Karoline Schousboe, MD, PhD, +45 5142 6110, Karoline.Schousboe@rsyd.dk
Ib Abildgaard, MD, DMSc, +45 6611 3333, Ib.Abildgaard@rsyd.dk
About this study
Official title: A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA
- Conditions
- Renal Artery Obstruction, Hypertension, Renovascular, Cardiovascular Diseases, Kidney Diseases
- Being tested
- Percutaneous transluminal renal angioplasty
- Medical subject headings
- Renal Artery Obstruction, Hypertension, Renovascular, Cardiovascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal renal angioplastyDevice
Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia)
Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician
- Antiplatelet therapy (usually standard)
- Cholesterol-lowering drugs (usually standard)
- Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated)
- Smoking cessation, diet and physical activity (usually standard)
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis either
- Unilaterally (one or two kidneys)
- Bilaterally with treatment of both kidneys
All 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication. Likewise, it will below be inferred that renal artery stenosis is defined as in the primary endpoint.
Measured: Measured 24 months post-PTRA
Secondary outcomes (8)
Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis
Measured: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis
Measured: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis
Measured: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes)
Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) from baseline to 3, 12, 36, 48 and 60 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg and in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg
Measured: Measured at 3, 12, 36, 48 and 60 months
Change in antihypertensive treatment (defined daily doses)
Measured: Measured at 3, 12, 24, 36, 48 and 60 months
Change in kidney function
Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA
Measured: Measured at 3, 12, 24, 36, 48 and 60 months
Clinical composite end point
Clinical composite end point
- death from cardiovascular causes
- death from renal causes
- stroke
- myocardial infarction
- hospitalization for congestive heart failure
- progressive renal insufficiency (a reduction from baseline of 30% or more in eGFR)
- permanent renal-replacement therapy
Only the first event per participant is included in the composite
Measured: Measured at 3, 12, 24, 36, 48 and 60 months
Safety composite end point (< 30 days after PTRA)
Safety composite end point (< 30 days after PTRA)
- all cause mortality
- rupture, dissection, perforation or occlusion of renal artery
- critical bleeding (need of blood transfusion)
- embolization
- significant loss of kidney function (reduction from baseline of 30% or more in eGFR)
- ipsilateral nephrectomy
- pseudoaneurysm formation
- stent thrombosis
Only the first event per participant is included in the composite
Measured: Measured at 3, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start1 Jan 2015
- Primary completionJan 2030 (estimated)
- Study completionJan 2035 (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 Renal Artery ObstructionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Reinhard, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770066
- Sponsor's protocol ID
- DAN-PTRA
- Acronym
- DAN-PTRA
- Status last verified
- Dec 2025
- First submitted
- 9 May 2016
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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