Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients with Uncontrolled Hypertension: the RESTART Study - RESTART

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

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•1. Age >= 18 years
•2. Kidney transplantation >= 12 months ago with stable immunosuppressive drug
•treatment (dosage changes to maintain a steady serum concentration are
•3. Estimated Glomerular Filtration Rate (eGFR) >= 40 ml/min/1.73m2
•4. Office systolic blood pressure >= 140 mmHg at screening (V0), and a systolic
•mean 24-hour ambulatory blood pressure >= 130 mmHg (V1)
•5. With respect to antihypertensive medication:
•a. Patients should be on a stable regimen of at least two antihypertensive
•drugs of different classes, including a diuretic (defined a thiazide diuretic,
•loop diuretic or mineralocorticoid receptor antagonist), for at least three
•b. Patients should have a documented intolerance to three classes of
•antihypertensive drugs.
•Patients should only be included when a change in antihypertensive drug regimen
•is not anticipated within the oncoming three months.
•6. Patient is willing and able to provide written informed consent

•Native renal artery anatomy not eligible for renale denervatie, defined as at least one of the following conditions: o History of renal artery stenting or angioplasty o History of renal denervation o History of kidney tumors o Renal artery diameter < 3 mm or > 8 mm o Renal artery length < 20 mm o Fibromuscular disease (FMD) of the native renal arteries o Renal artery aneurysm o Renal artery stenosis > 30% • Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys • Solitary native kidney • History of intravenous contrast dye allergy or nephropathy • Iliac/femoral artery stenosis precluding insertion of the Paradise catheter • Uncorrected, treatable secondary cause of hypertension • Pregnancy • Life expectancy < one year at the discretion of the investigator

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