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NCT Number: NCT02770066

A Prospective Danish National Registry of PTRA 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

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Key information

Conditions

Renal Artery Obstruction Arterial Occlusive Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Renal Hypertension, Renovascular Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Percutaneous transluminal renal angioplasty

Device

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)

Primary outcomes

  1. 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

    Time frame: Measured 24 months post-PTRA

    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.

Secondary outcomes

  1. 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

    Time frame: Measured 24 months post-PTRA

    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

  2. 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

    Time frame: Measured 24 months post-PTRA

    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

  3. 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

    Time frame: Measured 24 months post-PTRA

    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

  4. Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes)

    Time frame: Measured at 3, 12, 36, 48 and 60 months

    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

  5. Change in antihypertensive treatment (defined daily doses)

    Time frame: Measured at 3, 12, 24, 36, 48 and 60 months

  6. Change in kidney function

    Time frame: Measured at 3, 12, 24, 36, 48 and 60 months

    Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA

  7. Clinical composite end point

    Time frame: Measured at 3, 12, 24, 36, 48 and 60 months

    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

  8. Safety composite end point (< 30 days after PTRA)

    Time frame: Measured at 3, 12, 24, 36, 48 and 60 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kent L Christensen, MD, DMSc

CONTACT

[email protected]

+45 7845 2455

Mark Reinhard, PhD

CONTACT

[email protected]

+45 7845 2455

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: DAN-PTRA

Important dates

Study start
2015
Primary completion
2030
Study completion
2035
First posted
May 12, 2016
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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