Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic 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.
University of Aarhus
80 participants
Jun 26, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
- In addition, at least one of the following high-risk clinical syndromes:
- 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.
- All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.
Exclusion Criteria17
- 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:
- 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.
- 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
Interventions
* 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
* 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
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05834803