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NCT02770066 | RECRUITING | Renal Artery Obstruction

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

University of Aarhus

Information provided by (Responsible Party):

Mark Reinhard

Brief 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

Condition or disease

Renal Artery Obstruction

Hypertension, Renovascular

Cardiovascular Diseases

Kidney Diseases

Intervention/treatment

Percutaneous transluminal renal angioplasty

Study Type : OBSERVATIONAL
Estimated Enrollment : 160 participants
Official Title : A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
Actual Study Start Date : 2015-01-01
Estimated Primary Completion Date : 2030-01
Estimated Study Completion Date : 2035-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Eligibility criteria
  • 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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
      • 1. At least one of the above eligibility criteria
      • 2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis
      • 3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection
      Exclusion Criteria
      • 1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA
      • 2. 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)
    • A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

    Location Details

    NCT02770066

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    Denmark,

    Aalborg University Hospital

    Aalborg, Denmark, 9000

    RECRUITING

    Denmark,

    Aarhus University Hospital

    Aarhus N, Denmark, 8200

    RECRUITING

    Denmark,

    Glostrup University Hospital/ Rigshospitalet

    Glostrup Municipality, Denmark, 2600

    RECRUITING

    Denmark,

    Holbaek Hospital

    Holbæk, Denmark, 4300

    RECRUITING

    Denmark,

    Odense University Hospital

    Odense C, Denmark, 5000