Percutaneous angioplasty for severe renal artery stenosis in high-risk patients

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.

This study is testing if a procedure called renal artery stenting can help high-risk patients with narrowed kidney arteries manage their blood pressure and improve kidney function better than just taking medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (Academic / other)
• Locations: 3 sites (Aarhus N and 2 other locations)
• Trial ID: NCT05834803 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of percutaneous transluminal renal angioplasty (PTRA) with stent placement in patients suffering from atherosclerotic renal artery stenosis who are at high risk for cardiovascular events. Participants will be randomly assigned to receive either renal artery stenting or a sham treatment, with both groups receiving optimal medical therapy. The study will assess outcomes such as blood pressure control, kidney function improvement, and hospitalization rates for heart failure over a follow-up period of six months. The trial is designed to provide high-quality evidence on the benefits of renal artery stenting compared to medical treatment alone.

Who should consider this trial

Good fit: Ideal candidates include patients with severe atherosclerotic renal artery stenosis and high-risk clinical syndromes such as resistant hypertension or rapidly declining kidney function.

Not a fit: Patients with mild renal artery stenosis or those who do not meet the high-risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved blood pressure control and kidney function in high-risk patients with renal artery stenosis.

How similar studies have performed: Previous studies, including the CORAL trial, have shown mixed results, making this approach both relevant and potentially novel in its specific patient selection criteria.

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

Where this trial is running

Aarhus N and 2 other locations

• Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Odense University Hospital — Odense C, Denmark (Recruiting)

Study contacts

• Principal investigator: Mark Reinhard, MD, PhD — Aarhus University Hospital
• Study coordinator: Sebastian Nielsen, MD

Conditions Renovascular Hypertension; Renovascular Hypertension With Renal Failure; Heart Failure; Renal Artery Stenosis Atherosclerotic; Percutaneous Transluminal Angioplasty