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

Last updated: May 8, 2024
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

Percutaneous transluminal renal angioplasty

Clinical Study ID

NCT02770066
DAN-PTRA
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Eligibility criteria

  1. True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, iftolerated, and each prescribed at optimal doses) and uncontrolled blood pressureconfirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatoryblood pressure monitoring is performed after nurse-administered medication and bloodpressure measurements are performed hourly. If the average 24-hour ambulatory systolicblood 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-hourambulatory blood pressure monitoring is performed after nurse-administered medicationand blood pressure measurements are performed hourly. If the average 24-hourambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated forrenal artery stenosis.
  3. Progressive renal insufficiency (a reduction in eGFR > 5 ml/min/1,73 m2 per year) inpatients with bilateral renal artery stenosis or in patients with renal arterystenosis and only one kidney.
  4. Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3antihypertensive drugs including a diuretic, if tolerated, and each prescribed atoptimal doses) that may not be attributed to non-compliance, reduced left heartventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatorysystolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patientcan be evaluated for renal artery stenosis.
  5. Younger patients (< 40 years) with hypertension (24-hour ambulatory blood pressuremonitoring ≥ 130/80 mmHg after nurse-administered medication ) Inclusion Criteria: All of the following:
  6. At least one of the above eligibility criteria
  7. Duplex doppler ultrasonography or renography investigations consistent withhemodynamically significant renal artery stenosis
  8. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection

Exclusion

Exclusion Criteria:

  1. If angiography/arteriography, ultrasonography or renography is consistent withbilateral 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 totalkidney function (with no blockage of the renin-angiotensin system) and has a kidneysize < 7 cm (length)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Percutaneous transluminal renal angioplasty
Phase:
Study Start date:
January 01, 2015
Estimated Completion Date:
January 31, 2030

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Glostrup University Hospital/ Rigshospitalet

    Glostrup, 2600
    Denmark

    Active - Recruiting

  • Holbaek Hospital

    Holbaek, 4300
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense C, 5000
    Denmark

    Active - Recruiting

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