Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis i… (NCT05834803) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Denmark80 participantsStarted 2023-06-26
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Treatment-resistant heart failure episodes presumed caused by renovascular disease.
What they're measuring
1
Change in 24-hour ambulatory systolic blood pressure
✕. 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: