Ultrasound renal denervation for uncontrolled high blood pressure after kidney transplant
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study
This study will try ultrasound renal denervation on the native kidneys to see if it lowers blood pressure in kidney transplant patients whose hypertension is not controlled by medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05934383 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm study enrolling 40 kidney transplant recipients with uncontrolled hypertension despite medication (or documented medication intolerance) to receive bilateral ultrasound renal denervation of their native kidneys using the Paradise® system. Participants must be at least 12 months post-transplant, have stable immunosuppression and an eGFR ≥40 ml/min/1.73m2. The study will track office and 24-hour ambulatory blood pressure, antihypertensive medication use and adherence, and procedure safety over short-term and long-term follow-up. Results will address a gap because prior randomized RDN trials excluded patients with prior renal failure or transplantation.
Who should consider this trial
Good fit: Adults at least 12 months after kidney transplant with stable immunosuppression, eGFR ≥40 ml/min/1.73m2, and persistent high office and 24-hour ambulatory systolic blood pressure despite a stable regimen of at least two antihypertensives (including a diuretic) or documented intolerance to multiple drug classes.
Not a fit: Patients with unsuitable native renal artery anatomy (for example prior renal artery stenting or prior RDN), low eGFR, recent transplant or those whose blood pressure is already controlled on medication are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the procedure could lower blood pressure and potentially reduce the need for antihypertensive drugs in transplant recipients, which may lower cardiovascular risk and help preserve graft function.
How similar studies have performed: Randomized trials in non‑transplant populations have shown that renal denervation can safely lower blood pressure, but kidney transplant recipients were excluded from those trials so its effect in this group is currently untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Joost Daemen, MD PhD
- Email: j.daemen@erasmusmc.nl
- Phone: +31107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.