HypertensionPhase 2RNSNCT02496117
Renal Nerves Stimulation Study
A Phase 2 study testing Electrical mapping, nerve stimulation checked renal denervation procedure and Electrial mapping, nerve stimulation guided renal denervation procedure in people with Hypertension and Renal Denervation, run by Diagram B.V. at 1 site in Netherlands.
Trial summary
Study design: Investigator initiated, single centre, feasibility study Main objectives are twofold: 1. To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Renal Denervation
- What is being tested?
- Electrical mapping, nerve stimulation checked renal denervation procedure and Electrial mapping, nerve stimulation guided renal denervation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Mar 2014to 4 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- Age 18-80 years
- The patient has hypertension and is accepted for renal denervation or combined pulmonary bein isolation and renal denervation
- Glomerular filtration rate >45 mL/min
- No history of renal artery stenosis
Who cannot join
- Type 1 diabetes mellitus
- Contraindication to chronic anticoagulation therapy or heparin.
- Chronic oxygen use
- Primary pulmonary hypertension
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
- Known secondary cause of hypertension
Show all 9Show fewer
- Mental or physical inability to participate in the study.
- Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm.
- Dual or triple ipsilateral renal artery ostia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Electrical Mapping and Stimulation of Renal Arteries in Patients Undergoing Renal Denervation
Study design: Investigator initiated, single centre, feasibility study
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Study population: 40 patients (18 - 80 yr old)
Read the detailed description
Background: Approximately 10-15% of adults with hypertension are considered to be treatment resistant because their hypertension is uncontrolled despite taking three or more drugs that includes a diuretic. Renal denervation (RDN) is a novel treatment option for therapy resistant hypertension and its rationale originates in denervating the renal sympathetic efferent and afferent coupling with the central autonomic nervous system. By denervating the renal arteries, general sympathetic tone is reduced. Currently, RDN is performed by placing in a spiral pattern 5-6 ablation lesions in each renal artery. 15-30% of the patients do not have any benefit from this procedure. The reason for this is unknown. Experimental data show that renal nerve stimulation (RNS) may serve as a functional endpoint to assess completeness of the RDN procedure. A RNS-guided RDN may prove to be superior to standard RDN (RNS-checked) in blood pressure control.
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Secondary objective:
The secondary objective is to compare both techniques (RNS-checked vs. RNS-guided) in terms of efficacy and safety.
Hypotheses:
- We hypothesize that identification and localization of the sympathetic nerve bundles using 3D navigation systems and selective pacing manoeuvres will allow a functional approach to denervate the kidneys and improve the success rate of this procedure in patients with hypertension.
- We hypothesize that the RNS-guided RDN procedure will show better blood pressure data during follow up, since the completeness has been assessed in contrast to the RNS-checked RDN procedure.
Study design: Investigator initiated, single centre, prospective, feasibility study
Study population: 40 patients (18 - 80 yr old)
- 20 patients treated with RNS-checked RDN
- 20 patients treated with RNS-guided RDN
Intervention:
Two different techniques will be used in this trial:
- RNS-checked RDN
- RNS-guided RDN
Main study endpoints:
Main study parameter will be the arterial blood pressure response to RNS prior to RDN and absence of blood pressure rise in response to pacing in the renal artery after RDN.
Secondary study endpoints:
Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention.
- Conditions
- Hypertension, Renal Denervation
- Being tested
- Electrical mapping, nerve stimulation checked renal denervation procedure, Electrial mapping, nerve stimulation guided renal denervation procedure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical mapping, nerve stimulation checked renal denervation procedureProcedure or surgery
Also called RNS-checked RDN
Electrial mapping, nerve stimulation guided renal denervation procedureProcedure or surgery
Also called RNS-guided RDN
| Study group | Role | What they receive |
|---|---|---|
| RNS-checked RDN | Active comparator | 20 patients with hypertension will be enrolled undergoing RNS-checked RDN Receives: Procedure: Electrical mapping, nerve stimulation checked renal denervation procedure |
| RNS-guided RDN | Experimental | 20 patients with hypertension will be enrolled undergoing RNS-guided RDN Receives: Procedure: Electrial mapping, nerve stimulation guided renal denervation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood pressure response
Main study parameter will be the arterial blood pressure response to RNS prior to renal denervation and absence of blood pressure rise in response to pacing in the renal artery after RDN.
Measured: during procedure
Secondary outcomes (4)
blood pressure at 3 months
Blood pressure at 3 months after the intervention
Measured: 3 months after the intervention
blood pressure at 6 months
Blood pressure at 6 months after the intervention
Measured: 6 months after the intervention
blood pressure at 12 months
Blood pressure at 12 months after the intervention
Measured: 12 months after the intervention
change in blood pressure compared to measurement before the intervention
change in blood pressure compared to measurement before the intervention
Measured: intervention - up to 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start14 Mar 2014
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- RNS checked RDN
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496117
- Sponsor's protocol ID
- 9209
- Acronym
- RNS
- Status last verified
- May 2020
- First submitted
- 7 Jul 2015
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hoogerwaard AF, Adiyaman A, de Jong MR, Smit JJ, Heeg JE, van Hasselt BAAM, Elvan A. Renal nerve stimulation: complete versus incomplete renal sympathetic denervation. Blood Press. 2021 Dec;30(6):376-385. doi: 10.1080/08037051.2021.1982376. Epub 2021 Oct 14.
PubMed 34647513
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Electrical Mapping and Stimulation of Renal Arteries in Patients Undergoing Renal Denervation
- ClinicalTrials.gov ID
- NCT02496117
- Acronym / sponsor ID
- RNS / 9209
- Conditions
- Hypertension, Renal Denervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Study design: Investigator initiated, single centre, feasibility study
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Study population: 40 patients (18 - 80 yr old)
Detailed description
Background: Approximately 10-15% of adults with hypertension are considered to be treatment resistant because their hypertension is uncontrolled despite taking three or more drugs that includes a diuretic. Renal denervation (RDN) is a novel treatment option for therapy resistant hypertension and its rationale originates in denervating the renal sympathetic efferent and afferent coupling with the central autonomic nervous system. By denervating the renal arteries, general sympathetic tone is reduced. Currently, RDN is performed by placing in a spiral pattern 5-6 ablation lesions in each renal artery. 15-30% of the patients do not have any benefit from this procedure. The reason for this is unknown. Experimental data show that renal nerve stimulation (RNS) may serve as a functional endpoint to assess completeness of the RDN procedure. A RNS-guided RDN may prove to be superior to standard RDN (RNS-checked) in blood pressure control.
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Secondary objective:
The secondary objective is to compare both techniques (RNS-checked vs. RNS-guided) in terms of efficacy and safety.
Hypotheses:
- We hypothesize that identification and localization of the sympathetic nerve bundles using 3D navigation systems and selective pacing manoeuvres will allow a functional approach to denervate the kidneys and improve the success rate of this procedure in patients with hypertension.
- We hypothesize that the RNS-guided RDN procedure will show better blood pressure data during follow up, since the completeness has been assessed in contrast to the RNS-checked RDN procedure.
Study design: Investigator initiated, single centre, prospective, feasibility study
Study population: 40 patients (18 - 80 yr old)
- 20 patients treated with RNS-checked RDN
- 20 patients treated with RNS-guided RDN
Intervention:
Two different techniques will be used in this trial:
- RNS-checked RDN
- RNS-guided RDN
Main study endpoints:
Main study parameter will be the arterial blood pressure response to RNS prior to RDN and absence of blood pressure rise in response to pacing in the renal artery after RDN.
Secondary study endpoints:
Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RNS checked RDN
| Arm | Type | Receives |
|---|---|---|
| RNS-checked RDN | Active comparator | Procedure: Electrical mapping, nerve stimulation checked renal denervation procedure20 patients with hypertension will be enrolled undergoing RNS-checked RDN |
| RNS-guided RDN | Experimental | Procedure: Electrial mapping, nerve stimulation guided renal denervation procedure20 patients with hypertension will be enrolled undergoing RNS-guided RDN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- Age 18-80 years
- The patient has hypertension and is accepted for renal denervation or combined pulmonary bein isolation and renal denervation
- Glomerular filtration rate >45 mL/min
- No history of renal artery stenosis
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus
- Contraindication to chronic anticoagulation therapy or heparin.
- Chronic oxygen use
- Primary pulmonary hypertension
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
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 |
|---|---|---|
| Electrical mapping, nerve stimulation checked renal denervation procedureAlso: RNS-checked RDN | Procedure or surgery | RNS-checked RDN |
| Electrial mapping, nerve stimulation guided renal denervation procedureAlso: RNS-guided RDN | Procedure or surgery | RNS-guided RDN |
Primary outcome
arterial blood pressure response
Time frame: during procedure
Main study parameter will be the arterial blood pressure response to RNS prior to renal denervation and absence of blood pressure rise in response to pacing in the renal artery after RDN.
4 secondary outcomes
blood pressure at 3 months
Time frame: 3 months after the intervention
blood pressure at 6 months
Time frame: 6 months after the intervention
blood pressure at 12 months
Time frame: 12 months after the intervention
change in blood pressure compared to measurement before the intervention
Time frame: intervention - up to 12 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Derived from this study: PubMed 34647513Hoogerwaard AF, Adiyaman A, de Jong MR, Smit JJ, Heeg JE, van Hasselt BAAM, Elvan A. Renal nerve stimulation: complete versus incomplete renal sympathetic denervation. Blood Press. 2021 Dec;30(6):376-385. doi: 10.1080/08037051.2021.1982376. Epub 2021 Oct 14.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electrical mapping, nerve stimulation checked renal denervation procedure and Electrial mapping, nerve stimulation guided renal denervation procedure in people with Hypertension and Renal Denervation, run by Diagram B.V. 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 6 May 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood pressure response (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496117, which also lists 1 linked publication.
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 6 May 2020.