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

Summary

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

Conditions

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

Interventions

DRUG

Optimal medical therapy (OMT)

Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.

DIAGNOSTIC_TEST

Catheter-based angiography

Catheter-based angiography performed in accordance with the study protocol.

DIAGNOSTIC_TEST

Measurement of translesional pressure gradients

Measurement of translesional pressure gradients performed in accordance with the study protocol.

PROCEDURE

Renal artery stenting

Renal artery stenting performed in accordance with the study protocol.

PROCEDURE

Sham (No Treatment)

Sham procedure performed in accordance with the study protocol.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• The Novo Nordic Foundation

  collaborator OTHER

• The Augustinus Foundation, Denmark.

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Mark Reinhard, MD, PhD · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-26

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• Denmark

Study Locations