What is this study trying to find out about renovascular hypertension?

This study observes patients undergoing percutaneous transluminal renal angioplasty to better understand its effects on blood pressure and kidney function in renovascular hypertension. It collects data from high-risk patients treated at Danish centers to evaluate changes over time. Participants can expect careful monitoring of their blood pressure and kidney health throughout the study.

Who may be eligible for this renovascular hypertension clinical trial?

Adults with high-risk renovascular hypertension may be eligible, especially those with resistant hypertension or progressive kidney issues confirmed by blood pressure monitoring and imaging. Both men and women can join if they meet specific criteria including significant renal artery narrowing. Please review eligibility criteria for more details.

Is there any cost to participate in this renovascular hypertension clinical trial?

Study-related care, including the angioplasty procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively 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

Research Sites

260 weeks

Total Duration

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 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

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.

Research Team

Mark Reinhard, PhD

Kent L Christensen, MD, DMSc

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