Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Erasmus University Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Joost Daemen, MD PhD
j.daemen@erasmusmc.nl
+31107040704
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2030-09
Participants
Target number of participants: 40
Treatments
Experimental: Renal sympathetic denervation
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center
Collaborators: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov