Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study.
Mark Reinhard, Karoline Schousboe, Ulrik B Andersen...
https://pubmed.ncbi.nlm.nih.gov/35322677Actively Recruiting
All Genders
ID02770066
A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
Led by University of Aarhus · Updated on 2025-12-18
160
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective national registry in Denmark to observe and collect data on percutaneous transluminal renal angioplasty (PTRA) in patients who have high-risk renovascular hypertension. This registry includes patients selected based on common national criteria and follows a standardized protocol across three Danish centers offering PTRA. The study aims to evaluate changes in blood pressure and other health outcomes after the procedure. The intervention being studied is percutaneous transluminal renal angioplasty, including angioplasty with stenting, especially in patients with fibromuscular dysplasia. Additional treatments such as antiplatelet therapy, cholesterol-lowering drugs, antihypertensive medications, and lifestyle measures like smoking cessation, diet, and physical activity are used according to the physician's discretion. The study monitors patients over time following their PTRA treatment. Participants undergo regular assessments including 24-hour ambulatory blood pressure monitoring and kidney function tests. The primary outcome measured is the change in systolic and diastolic blood pressures 24 months after PTRA in patients with elevated baseline blood pressure. Secondary outcomes include blood pressure changes at multiple time points, adjustments in antihypertensive treatment, kidney function changes, clinical and safety endpoints. Follow-up evaluations occur up to 60 months post-treatment to monitor long-term effects and safety.
CONDITIONS
Brief Title
A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Have true resistant hypertension, defined as needing 3 or more blood pressure medications including a diuretic with uncontrolled blood pressure confirmed by 24-hour monitoring.
- Have hypertension with intolerance or side effects to blood pressure medications confirmed by 24-hour monitoring.
- Have progressive kidney function decline with bilateral renal artery stenosis or renal artery stenosis with only one kidney.
- Have recurrent heart failure or pulmonary edema with resistant hypertension not explained by other conditions.
- Are younger than 40 years with hypertension confirmed by 24-hour monitoring.
- Have imaging tests (duplex doppler ultrasonography or renography) consistent with significant renal artery narrowing.
- Have CT angiography or renal arteriography showing at least 70% narrowing of a renal artery in at least one view.
You will not qualify if you...
- Have bilateral significant renal artery stenosis but only one side is treated with PTRA.
- Have a kidney supplied by a treated renal artery that contributes 10% or less to total kidney function and is smaller than 7 cm in length before treatment.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo percutaneous transluminal renal angioplasty to treat renal artery narrowing.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants are monitored for changes in blood pressure, kidney function, and clinical outcomes for up to 60 months after the angioplasty procedure.
Visits at 3, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 5 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
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2
Aarhus University Hospital
Aarhus N, Denmark, 8200
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3
Glostrup University Hospital/ Rigshospitalet
Glostrup Municipality, Denmark, 2600
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4
Holbaek Hospital
Holbæk, Denmark, 4300
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5
Odense University Hospital
Odense C, Denmark, 5000
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Research Team
M
Mark Reinhard, PhD
K
Kent L Christensen, MD, DMSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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