HypertensionRESTARTNCT05934383
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
A study testing Paradise® ultrasound renal denervation system. in people with Hypertension and Kidney Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Kidney Transplantation
- What is being tested?
- Paradise® ultrasound renal denervation system.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Sep 2023to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam
Joost Daemen, MD PhD, +31107040704, j.daemen@erasmusmc.nl
About this study
Official title: Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study
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
Read the detailed description
The RESTART study is an investigator-initiated, prospective, single-center, single-arm interventional study investigating the safety and efficacy of bilateral native kidney RDN in 40 renal transplant patients with uncontrolled hypertension despite antihypertensive medication (or with a documented intolerance to antihypertensive drugs).
Previously, RDN demonstrated to safely reduce BP as compared to sham-control in multiple randomized clinical trials, both in patients with and without concomitant antihypertensive medication. Up until now, patients with a history of renal failure or kidney transplantation have been excluded from these studies. As the pathophysiology of hypertension is considered different in hypertensive renal transplant patients as compared to the previously studied populations (without kidney transplantation), the effect of native kidney RDN in hypertensive patients with a history of kidney transplantation remains unknown. The current study aims to provide novel insights on the safety and efficacy of RDN in this particular population. Adjustment for routine therapy adherence will also be performed as this proved to be an important confounding factor in previous research.
- Conditions
- Hypertension, Kidney Transplantation
- Being tested
- Paradise® ultrasound renal denervation system.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paradise® ultrasound renal denervation system.Device
Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Experimental | Not described Receives: Device: Paradise® ultrasound renal denervation system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: change in mean 24-hour ambulatory systolic blood pressure
Measured: 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
Measured: Baseline vs. 3-month follow-up
Secondary outcomes (20)
Efficacy: change in mean 24-hour ambulatory diastolic blood pressure
Measured: Baseline vs. 3-month follow-up
Efficacy: change in daytime ambulatory systolic and diastolic blood pressure
Measured: Baseline vs. 3-month follow-up
Efficacy: change in nighttime ambulatory systolic and diastolic blood pressure
Measured: Baseline vs. 3-month follow-up
Efficacy: change in office systolic and diastolic blood pressure
Measured: Baseline vs. 3-month follow-up
Efficacy: changes in ambulatory (mean 24-hour, daytime, nighttime) systolic and diastolic blood pressure
In a subpopulation of patients with an equal level of therapy adherence at both timepoints
Measured: Baseline vs. 3-month follow-up
Efficacy: changes in office systolic and diastolic blood pressure
In a subpopulation of patients with an equal level of therapy adherence at both timepoints
Measured: Baseline vs. 3-month follow-up
Efficacy: changes in the number of prescribed defined daily dosages and number of classes of antihypertensive drugs
Measured: Baseline vs. 3-month follow-up
Efficacy: change in the percentage therapy adherence
The percentage adherence will be calculated as the proportion of drugs that could be detected using dried blood spot testing out of all drugs prescribed to the patient at the time of the testing.
Measured: Baseline vs. 3-month follow-up
Efficacy: annual changes in ambulatory (mean 24-hour, daytime, nighttime) systolic and diastolic blood pressure
Measured: Baseline up until and including 5-year follow-up
Efficacy: annual changes in office systolic and diastolic blood pressure
Measured: Baseline up until and including 5-year follow-up
Efficacy: annual changes in in the number of prescribed defined daily dosages and number of classes of antihypertensive drugs
Measured: Baseline up until and including 5-year follow-up
Efficacy: annual change in the percentage therapy adherence
The percentage adherence will be calculated as the proportion of drugs that could be detected using dried blood spot testing out of all drugs prescribed to the patient at the time of the testing.
Measured: Baseline up until and including 5-year follow-up
Safety: the number of patients in whom no successful bilateral renal denervation procedure can be performed
E.g. due to anatomical difficulties
Measured: Periprocedural
Safety: change in renal function (estimated Glomerular Filtration Rate)
Measured: Baseline vs. 3-month follow-up
Safety: change in renal function (urine protein/creatinine ratio)
Measured: Baseline vs. 3-month follow-up
Safety: occurrence of the individual components of the primary safety outcome
- 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
Measured: Baseline up until and including 5-year follow-up
Safety: occurrence of any major adverse cardiovascular and cerebrovascular event (MACCE)
Including myocardial infarction, coronary revascularization, stroke and cardiovascular mortality
Measured: Baseline up until and including 5-year follow-up
Safety: occurrence of the individual components of major adverse cardiovascular and cerebrovascular event (MACCE)
Including myocardial infarction, coronary revascularization, stroke and cardiovascular mortality
Measured: Baseline up until and including 5-year follow-up
Safety: annual change in renal function (estimated Glomerular Filtration Rate)
Measured: Baseline up until and including 5-year follow-up
Safety: annual change in renal function (urine protein/creatinine ratio)
Measured: Baseline up until and including 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start4 Sep 2023
- Primary completionJan 2026 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ReCor Medical, Inc.
- Responsible party
- Principal investigator, Joost Daemen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934383
- Sponsor's protocol ID
- RESTART - renal denervation
- Acronym
- RESTART
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study
- ClinicalTrials.gov ID
- NCT05934383
- Acronym / sponsor ID
- RESTART / RESTART - renal denervation
- Conditions
- Hypertension, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ReCor Medical, Inc.
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The RESTART study is an investigator-initiated, prospective, single-center, single-arm interventional study investigating the safety and efficacy of bilateral native kidney RDN in 40 renal transplant patients with uncontrolled hypertension despite antihypertensive medication (or with a documented intolerance to antihypertensive drugs).
Previously, RDN demonstrated to safely reduce BP as compared to sham-control in multiple randomized clinical trials, both in patients with and without concomitant antihypertensive medication. Up until now, patients with a history of renal failure or kidney transplantation have been excluded from these studies. As the pathophysiology of hypertension is considered different in hypertensive renal transplant patients as compared to the previously studied populations (without kidney transplantation), the effect of native kidney RDN in hypertensive patients with a history of kidney transplantation remains unknown. The current study aims to provide novel insights on the safety and efficacy of RDN in this particular population. Adjustment for routine therapy adherence will also be performed as this proved to be an important confounding factor in previous research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Experimental | Device: Paradise® ultrasound renal denervation system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (16 listed)
- Native renal artery anatomy not eligible for RDN, defined as at least one of the following conditions:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paradise® ultrasound renal denervation system.Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system. | Device | Renal sympathetic denervation |
Primary outcome
Efficacy: change in mean 24-hour ambulatory systolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Safety: occurrence of the composite endpoint
Time frame: Baseline vs. 3-month follow-up
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
20 secondary outcomes
Efficacy: change in mean 24-hour ambulatory diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: change in daytime ambulatory systolic and diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: change in nighttime ambulatory systolic and diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: change in office systolic and diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: changes in ambulatory (mean 24-hour, daytime, nighttime) systolic and diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: changes in office systolic and diastolic blood pressure
Time frame: Baseline vs. 3-month follow-up
Efficacy: changes in the number of prescribed defined daily dosages and number of classes of antihypertensive drugs
Time frame: Baseline vs. 3-month follow-up
Efficacy: change in the percentage therapy adherence
Time frame: Baseline vs. 3-month follow-up
Efficacy: annual changes in ambulatory (mean 24-hour, daytime, nighttime) systolic and diastolic blood pressure
Time frame: Baseline up until and including 5-year follow-up
Efficacy: annual changes in office systolic and diastolic blood pressure
Time frame: Baseline up until and including 5-year follow-up
Efficacy: annual changes in in the number of prescribed defined daily dosages and number of classes of antihypertensive drugs
Time frame: Baseline up until and including 5-year follow-up
Efficacy: annual change in the percentage therapy adherence
Time frame: Baseline up until and including 5-year follow-up
Safety: the number of patients in whom no successful bilateral renal denervation procedure can be performed
Time frame: Periprocedural
Safety: change in renal function (estimated Glomerular Filtration Rate)
Time frame: Baseline vs. 3-month follow-up
Safety: change in renal function (urine protein/creatinine ratio)
Time frame: Baseline vs. 3-month follow-up
Safety: occurrence of the individual components of the primary safety outcome
Time frame: Baseline up until and including 5-year follow-up
Safety: occurrence of any major adverse cardiovascular and cerebrovascular event (MACCE)
Time frame: Baseline up until and including 5-year follow-up
Safety: occurrence of the individual components of major adverse cardiovascular and cerebrovascular event (MACCE)
Time frame: Baseline up until and including 5-year follow-up
Safety: annual change in renal function (estimated Glomerular Filtration Rate)
Time frame: Baseline up until and including 5-year follow-up
Safety: annual change in renal function (urine protein/creatinine ratio)
Time frame: Baseline up until and including 5-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paradise® ultrasound renal denervation system. in people with Hypertension and Kidney Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joost Daemen, MD PhD (+31107040704, j.daemen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: change in mean 24-hour ambulatory systolic blood pressure (time frame: Baseline vs. 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.