Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension (RESTART)
Hypertension, Kidney Transplantation

About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Kidney transplantation ≥ 12 months ago with stable immunosuppressive drug treatment Estimated Glomerular Filtration Rate (eGFR) ≥ 40 ml/min/1.73m2 Office systolic BP ≥ 140 mmHg and a mean 24-hour ambulatory systolic BP ≥ 130 mmHg at screening Antihypertensive medication regimen: 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 months, or Documented intolerance to three classes of antihypertensive drugs, and A change in antihypertensive drug regimen is not anticipated within the oncoming three months. Patient is willing and able to provide written informed consent Exclusion Criteria: Native renal artery anatomy not eligible for RDN, defined as at least one of the following conditions: History of renal artery stenting or angioplasty History of renal denervation History of kidney tumors Renal artery diameter < 3 mm or > 8 mm Renal artery length < 20 mm Fibromuscular disease (FMD) of the native renal arteries Renal artery aneurysm 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Renal sympathetic denervation