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NCT02770066Recruiting

A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
160 (estimated)
First submitted
9 May 2016
Start date
Jan 2015
Primary completion date
Jan 2030
Lead sponsor
University of Aarhus
NCT number
NCT02770066

What you commit to

  • Study type: Observational
  • Planned participants: 160
  • From Jan 2015 to the primary completion date, Jan 2030
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA

Other

  • 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)

Who the study is looking for

  • 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

Criteria the registry did not label

  • Eligibility criteria
  • True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
  • Hypertension and intolerance or side effects of the antihypertensive treatment. Hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
  • Progressive renal insufficiency (a reduction in eGFR \> 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney.
  • Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patient can be evaluated for renal artery stenosis.
  • Younger patients (\< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmHg after nurse-administered medication )

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital
Coordinator of this site? Confirm its status
AalborgDenmarkRecruiting
Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Glostrup University Hospital/ Rigshospitalet
Coordinator of this site? Confirm its status
Glostrup MunicipalityDenmarkRecruiting
Holbaek Hospital
Coordinator of this site? Confirm its status
HolbækDenmarkRecruiting
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.