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

Launched by ERASMUS MEDICAL CENTER · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called bilateral ultrasound renal sympathetic denervation (RDN) for kidney transplant patients who have high blood pressure that is hard to control. The goal of the study is to see if this treatment can help lower blood pressure in these patients both in the short term and long term, as well as to check if it is safe to use. Researchers will also look at how this treatment affects the number of blood pressure medications patients need and how well they stick to their medication routines.

To be part of this trial, participants need to be at least 18 years old and have had a kidney transplant more than a year ago. They should have high blood pressure that remains high despite taking at least two different types of blood pressure medicines. Participants will be monitored closely to see how their blood pressure changes after the treatment and whether it leads to any side effects. It's important to note that this study is not yet recruiting patients, so there will be more details to come for those who may be interested in participating.

Gender

ALL

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