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

NCT ID: NCT05834803

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2027-06-01

Brief 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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Renal artery stenting

Percutaneous transluminal renal angioplasty with stent placement

Group Type: ACTIVE_COMPARATOR

Renal artery stenting

Intervention Type: PROCEDURE

• Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker
• Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients
• Treatment: Renal artery stenting performed according to the study protocol

Sham procedure

Sham procedure

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: PROCEDURE

• Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker
• Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients
• Treatment: Sham

Interventions

Sham procedure

• Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker
• Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients
• Treatment: Sham

Intervention Type: PROCEDURE

Renal artery stenting

• Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker
• Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients
• Treatment: Renal artery stenting performed according to the study protocol

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Amsterdam UMC

OTHER

Sponsor Role: collaborator

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

The Augustinus Foundation, Denmark.

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Reinhard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Site Status: RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Odense University Hospital

Odense C, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sebastian Nielsen, MD

Role: CONTACT

sebane@rm.dk

+45 23100484

Mark Reinhard, MD, PhD

Role: CONTACT

m.reinhard@dadlnet.dk

+45 40460321

Facility Contacts

Sebastian Nielsen, MD

Role: primary

sebane@rm.dk

Mark Reinhard, MD, PhD

Role: backup

markrein@rm.dk

Jonas P Eiberg, MD, PhD

Role: primary

jonas.peter.eiberg@regionh.dk

Michael D Schultz, MD

Role: primary

michael.dyrehauge.schultz@rsyd.dk

References

Horne AL, Dapolite LA. Protocol for pharmacist management of antineoplastic drug-induced adverse effects in outpatients. Am J Health Syst Pharm. 1997 Mar 15;54(6):680-3. doi: 10.1093/ajhp/54.6.680. No abstract available.

Reference Type: RESULT

PMID: 9075498 (View on PubMed)

Other Identifiers

DAN-PTRAII

Identifier Type: -

Identifier Source: org_study_id