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Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension

RecruitingNAAges 18 Years - anyAllErasmus Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Paradise® ultrasound renal denervation system.
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Where

1 site
Erasmus University Medical Center
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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