Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study
Erasmus Medical Center
40 participants
Sep 4, 2023
INTERVENTIONAL
Conditions
Summary
This prospective, single-arm, interventional study is designed to assess the short-term and long-term safety and efficacy of bilateral ultrasound renal sympathetic denervation (RDN) of the native kidneys in renal transplant patients with uncontrolled hypertension. Objectives: * To assess the short-term and long-term changes in ambulatory and office blood pressure (BP) following native kidney RDN in renal transplant patients * To assess the long-term safety of native kidney RDN in renal transplant patients * To assess the short-term and long-term change in antihypertensive drug prescriptions following native kidney RDN in renal transplant patients * To assess the short-term and long-term change in adherence to antihypertensive drugs following native kidney RDN in renal transplant patients
Eligibility
Inclusion Criteria9
- 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 Criteria16
- 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
Interventions
Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.
Locations(1)
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NCT05934383