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

NCT05934383 | Recruiting DMC

• 1 other identifier: RESTART - renal denervation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hypertension; Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• Efficacy: change in mean 24-hour ambulatory systolic blood pressure

  Baseline vs. 3-month follow-up

• Safety: occurrence of the composite endpoint

  Consisting of (whichever occurs first): * All-cause mortality * New onset (acute) end-stage renal disease (eGFR\< 15 mL/min/m2 or need for renal replacement therapy) * Significant embolic event resulting in end-organ damage * Renal artery perforation requiring an invasive intervention * Renal artery dissection requiring an invasive intervention * Major vascular complications * Hospitalization for hypertensive or hypotensive crisis

  Baseline vs. 3-month follow-up

Secondary Outcomes (20)

• Efficacy: change in mean 24-hour ambulatory diastolic blood pressure

  Baseline vs. 3-month follow-up

• Efficacy: change in daytime ambulatory systolic and diastolic blood pressure

  Baseline vs. 3-month follow-up

• Efficacy: change in nighttime ambulatory systolic and diastolic blood pressure

  Baseline vs. 3-month follow-up

• Efficacy: change in office systolic and diastolic blood pressure

  Baseline vs. 3-month follow-up

• Efficacy: changes in ambulatory (mean 24-hour, daytime, nighttime) systolic and diastolic blood pressure

  Baseline vs. 3-month follow-up

Study Arms (1)

Renal sympathetic denervation

EXPERIMENTAL

Device: Paradise® ultrasound renal denervation system.

Interventions

Paradise® ultrasound renal denervation system. DEVICE

Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.

Renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• ReCor Medical, Inc.: collaborator

Study Sites (1)

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Joost Daemen, MD PhD

CONTACT

+31107040704; j.daemen@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist, Principal Investigator

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 7, 2023
• Study Start: September 4, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

NL (1)