Actively Recruiting
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
Led by Erasmus Medical Center · Updated on 2025-06-26
40
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
R
ReCor Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Kidney transplantation at least 12 months ago with stable immunosuppressive drug treatment
- Estimated Glomerular Filtration Rate (eGFR) of 40 ml/min/1.73m2 or higher
- Office systolic blood pressure of 140 mmHg or higher and mean 24-hour ambulatory systolic blood pressure of 130 mmHg or higher at screening
- Stable regimen of at least two antihypertensive drugs of different classes, including a diuretic, for at least three months, or documented intolerance to three classes of antihypertensive drugs
- No anticipated changes in antihypertensive drug regimen within the next three months
- Willing and able to provide written informed consent
You will not qualify if you...
- Native renal artery anatomy unsuitable for renal denervation, including history of renal artery stenting or angioplasty, renal denervation, kidney tumors, renal artery diameter less than 3 mm or greater than 8 mm, renal artery length less than 20 mm, fibromuscular disease of the native renal arteries, renal artery aneurysm, or renal artery stenosis over 30%
- Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys
- Having only one native kidney
- History of intravenous contrast dye allergy or nephropathy
- Iliac or femoral artery stenosis preventing insertion of the Paradise catheter
- Untreated or correctable secondary causes of hypertension
- Pregnancy
- Life expectancy less than one year as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
Research Team
J
Joost Daemen, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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