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

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRA study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting.

The DAN-PTRAII study is a nationwide high-quality randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and his team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with optimal medical treatment alone on blood pressure, kidney function and hospitalizations due to heart failure. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Heart Failure
• Hypertension
• Hypertension, Renovascular
• Percutaneous Transluminal Angioplasty
• Renal Artery Obstruction
• Renovascular Hypertension

• NCT number: NCT05834803
• Study type: Interventional
• Source: University of Aarhus
• Contact: Sebastian Nielsen, MD
• Phone: +45 40460321
• Email: sebane@rm.dk
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Completion date: June 1, 2027