Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

Launched by UNIVERSITY OF AARHUS · Apr 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called percutaneous transluminal renal angioplasty (PTRA), which is used to treat narrowing of the renal arteries caused by atherosclerosis (a build-up of fatty deposits). The goal is to see if adding this procedure, along with the best medical treatment, can help improve blood pressure, kidney function, and reduce hospital stays for heart failure in patients who are at high risk for these conditions.

To be eligible for the trial, participants must be between 65 and 74 years old and have severe narrowing of the renal arteries (at least 70% blockage). They should also have one of the following high-risk conditions: high blood pressure that doesn’t respond to several medications, rapidly worsening kidney function, or recent hospitalizations for heart failure without clear reasons. If you or a loved one meets these criteria, you may be able to participate in this important study, which aims to provide valuable information about the benefits of this treatment option.

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Eligibility criteria

• Inclusion Criteria:
• • 1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
• 2. In addition, at least one of the following high-risk clinical syndromes:
• • 1. Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• • 2. Rapidly declining kidney function with a reduction in estimated GFR of \>5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• • 3. Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction \<40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• • All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.
• Exclusion Criteria:
• • Unable to provide informed consent.
• • Treatment resistant heart failure episodes presumed caused by renovascular disease.
• • Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
• • Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
• • Pregnancy or unknown pregnancy status in female of childbearing potential.
• • Kidney size \<7 cm (pole to pole length) supplied by target vessel.
• • Previous kidney transplant.
• • Previous PTRA treatment.
• • Presence of a renal artery stenosis not amenable for treatment with a stent.
• • Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.
• Patients treated with renal artery stenting without randomization in the study period include patients with:
• • 1. Treatment resistant heart failure episodes presumed caused by renovascular disease.
• • 2. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
• 3. At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:
• • a mean translesional gradient of ≥10 mm Hg, or
• • a systolic translesional gradient of ≥20 mm Hg, or
• • a renal fractional flow reserve (Pd/Pa) of ≤0.8