NCT05934383Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Jun 2023
- Start date
- 4 Sept 2023
- Primary completion date
- Jan 2026
- Lead sponsor
- Erasmus Medical Center
- Diseases
- High blood pressure
- NCT number
- NCT05934383
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 4 Sept 2023 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys
Other illness
- 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%
- History of intravenous contrast dye allergy or nephropathy
- Uncorrected, treatable secondary cause of hypertension
Other
- Solitary native kidney
- Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
- Pregnancy
- Life expectancy \< one year at the discretion of the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.