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/35322677/Actively Recruiting
Led by University of Aarhus · Updated on 2025-12-18
160
Participants Needed
5
Research Sites
260 weeks
Total Duration
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 physicians 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
A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
M
Mark Reinhard, PhD
K
Kent L Christensen, MD, DMSc
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University of Aarhus
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo percutaneous transluminal renal angioplasty to treat renal artery narrowing.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Mark Reinhard, Karoline Schousboe, Ulrik B Andersen...
https://pubmed.ncbi.nlm.nih.gov/35322677/University of Aarhus
Lead Sponsor