Percutaneous transluminal renal angioplasty: 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)
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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
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 — 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
1. Unilaterally (one or two kidneys)
2. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
