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
Eligibility Criteria
Inclusion
Eligibility criteria
- 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.
- 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.
- 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.
- 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.
- Younger patients (< 40 years) with hypertension (24-hour ambulatory blood pressuremonitoring ≥ 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 withhemodynamically 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
Exclusion Criteria:
- If angiography/arteriography, ultrasonography or renography is consistent withbilateral 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 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
DenmarkActive - Recruiting
Aarhus University Hospital
Aarhus N, 8200
DenmarkActive - Recruiting
Glostrup University Hospital/ Rigshospitalet
Glostrup, 2600
DenmarkActive - Recruiting
Holbaek Hospital
Holbaek, 4300
DenmarkActive - Recruiting
Odense University Hospital
Odense C, 5000
DenmarkActive - Recruiting
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