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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on:

* Blood pressure * Kidney function * Hospitalizations for heart failure

Eligibility criteria

Qualifiers

One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.

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.

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.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Optimal medical therapy (OMT)
  • Catheter-based angiography
  • Measurement of translesional pressure gradients
  • Renal artery stenting
  • Sham (No Treatment)

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Rigshospitalet, Denmark

Collaborator

Odense University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Gødstrup Hospital

Collaborator

Holbaek Sygehus

Collaborator

Amsterdam UMC

Collaborator

The Novo Nordic Foundation

Collaborator

The Augustinus Foundation, Denmark.

Collaborator