HypertensionNL_RDN_REGNCT02482103
The Dutch National Renal Denervation Registry
An observational study of Hypertension, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study is a national registry of patients treated with renal denervation (RD) in the Netherlands. The aim of the study is to collect data on safety of the procedure, predictors of the blood pressure lowering effect, sustainability of the effect and to assess the cardiovascular event rate in patients treated with… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal denervation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Apr 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with (or evaluated and refused for) renal denervation in Dutch hospitals. Indications for RD (by Dutch consensus) are therapy resistant hypertension defined as a blood pressure above treatment goal despite use of 3 or more antihypertensive agents preferably including a diuretic or intolerance for (additional) antihypertensives. Secondary hypertension is excluded beforehand.
Who may be able to join
- treated with renal denervation. The decision to perform the procedure was made by the treating physician in the participating hospitals
Who cannot join
- below age of 18 years
Trial locations and contacts
1 site in 1 country.
Michiel Bots, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Michiel L. Bots, Prof., +31(88)7559352, m.l.bots@umcutrecht.nl
Peter J. Blankestijn, MD, PhD, +31(88)7557329, p.j.blankestijn@umcutrecht.nl
About this study
Official title: Safety, Success Rate and Long Term Consequences of Renal Denervation in Patients With Therapy Resistant Hypertension. The Dutch National Renal Denervation Registry
This study is a national registry of patients treated with renal denervation (RD) in the Netherlands.
The aim of the study is to collect data on safety of the procedure, predictors of the blood pressure lowering effect, sustainability of the effect and to assess the cardiovascular event rate in patients treated with renal denervation.
This is a prospective observational study.
Read the detailed description
Hypertension is common and one of the major risk factors for cardiovascular disease. Therefore, it is a major societal and economic health problem. A substantial proportion (20-40%) of the treated hypertensive patients has sub-optimal blood pressure control despite the use of multiple drugs. All these patients have an increased cardio-vascular risk. Furthermore, the use of multiple drugs diminishes compliance to treatment, and increases the risk of side effects. This underscores the need for new approaches for hypertension management. Elevated (renal) sympathetic nerve activity contributes importantly to the development of hypertension and subsequent vascular risk. Deliberate disruption of sympathetic nerve activity (sympatholytic therapy) leads to improvement of vascular outcome through blood pressure dependent and blood pressure independent effects. Recently, a promising novel sympatholytic approach has been introduced, i.e. catheter-based renal denervation in a small clinical trial with resistant hypertensive patients. Many clinical centres have now started to perform this procedure or are in the process to start up.
The Dutch Minister of Health has decided to allow renal denervation in patients with so called resistant hypertension, and "conditional reimbursement" is available starting Jan 1st 2013 for a maximum of 4 years. The Netherlands Organisation for Health Research and Development (ZonMw) has provided us with a grant to perform a randomized trial (SYMPATHY) to evaluate the effect on blood pressure at 6 months after intervention. Maximum follow-up in this trial will be 2 years. Important limitations of this study are, firstly that that follow-up is limited to 2 years after renal denervation. Secondly, not all patients that undergo renal denervation, will participate in the abovementioned trial. The Dutch National Renal Denervation Registry will complement the information from the trial in several aspects. These deal with safety, non-responders, and sustainability.
Objectives of the national database are to collect data that will deliver information on:
Safety:
- What are the short and long term procedural related complications? Responders
- What are the predictors for the effect on blood pressure, in particular patient related factors and procedural related factors?
- Are there differences between the various renal denervation devices? Sustainability
- What is the effect on blood pressure after (3), 6, (9), 12, (18), 24, (30), 36, and 60 months and thereafter in patients who are considered eligible based on the judgement of the treating physician?
- What is the effect on kidney function after (3), 6, (9), 12, (18), 24, (30), 36, and 60 months and thereafter in patients who are considered eligible based on the judgement of the treating physician?
- What are the cardiovascular events rates in this population, in strata of achieved blood pressure level, and potentially compared with other populations.
Methods:
With this database a nationwide cohort is build comprising patients treated with renal denervation over the years, with uniform baseline data collection and uniform follow-up measurements in terms of safety measurements, blood pressure measurements, hospitalisations, cardiovascular outcomes and all-cause mortality. The data collection will occur through a web-based data entry application. All centers in the Netherlands that perform renal denervation will be asked to participate. All patients who underwent renal denervation should be included, irrespective of the reason and device used.
To address the outstanding research questions specific statistical analyses plans will be applied.
Conclusion:
Our expected results are:
- to be able to identify patients characteristics, which are associated with a high probability of a favourable blood pressure response to renal denervation,
- to provide short-and long-term (24 -60 months) side effects of renal denervation
Perspective:
These results, collected in routine clinical practice in a large number of clinics in the Netherlands, will have a major impact on the treatment of 'resistant hypertension'. The safety and efficacy data will pave the way for formal cost-effectiveness analyses. The data have the potential to be of high relevance to decision and policy makers in the government and health insurances. When deemed cost-effective and safe, this approach will be widely used in the treatment of 'resistant hypertension' and will revolutionise the treatment of these patients. Furthermore, it will open ways for evaluation of other groups of patients characterized by a high sympathetic tone; in particular patients with less severe hypertension, heart failure and chronic kidney disease.
- Conditions
- Hypertension
- Being tested
- Renal denervation
- Keywords
- Therapy resistant hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
Catheter based renal nerve ablation
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with renal denervation | Patients treated with RD in the Netherlands. The decision to perform RD was made by the treating physician in the participating hospitals. Receives: Procedure: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Change in blood pressure at 6 months
Measured: 6 months
Secondary outcomes (6)
safety aspects (change in renal function)
change in renal function
Measured: 5 years
safety aspects: long term kidney function
change in renal function
Measured: 5 years
longterm consequences: CVD events
cardiovascular event rates
Measured: 5 years
safety aspects: procedures complication
procedural complications
Measured: 1 year
longterm consequences: kidney function
change in kidney function
Measured: 5 years
longterm consequences: mortality
mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Responsible party
- Principal investigator, Michiel L. Bots, UMC Utrecht
- Investigators
- Michiel L. Bots, MD, PhD, Principal investigator, Julius Center for Health Sciences and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482103
- Sponsor's protocol ID
- NL-RDN_REG
- Acronym
- NL_RDN_REG
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vink EE, Bots ML, Blankestijn PJ. Renal denervation as therapy for hypertension: potentials and unanswered questions. Eur J Prev Cardiol. 2013 Dec;20(6):980-91. doi: 10.1177/2047487312473019. Epub 2012 Dec 19.
PubMed 23610453Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M, Leiner T. Effects of renal denervation on end organ damage in hypertensive patients. Eur J Prev Cardiol. 2015 May;22(5):558-67. doi: 10.1177/2047487314556003. Epub 2014 Oct 17.
PubMed 25326543Vink EE, Verloop WL, Bost RB, Voskuil M, Spiering W, Vonken EJ, Bots ML, Blankestijn PJ. The blood pressure-lowering effect of renal denervation is inversely related to kidney function. J Hypertens. 2014 Oct;32(10):2045-53; discussion 2053. doi: 10.1097/HJH.0000000000000282.
PubMed 25023158Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M. Renal denervation in multiple renal arteries. Eur J Clin Invest. 2014 Aug;44(8):728-35. doi: 10.1111/eci.12289.
PubMed 24931208Verloop WL, Vink EE, Voskuil M, Vonken EJ, Rookmaaker MB, Bots ML, Doevendans PA, Blankestijn PJ, Spiering W. Eligibility for percutaneous renal denervation: the importance of a systematic screening. J Hypertens. 2013 Aug;31(8):1662-8. doi: 10.1097/HJH.0b013e328362152e.
PubMed 23743806Persu A, Jin Y, Baelen M, Vink E, Verloop WL, Schmidt B, Blicher MK, Severino F, Wuerzner G, Taylor A, Pechere-Bertschi A, Jokhaji F, Fadl Elmula FE, Rosa J, Czarnecka D, Ehret G, Kahan T, Renkin J, Widimsky J Jr, Jacobs L, Spiering W, Burnier M, Mark PB, Menne J, Olsen MH, Blankestijn PJ, Kjeldsen S, Bots ML, Staessen JA; European Network Coordinating research on REnal Denervation Consortium. Eligibility for renal denervation: experience at 11 European expert centers. Hypertension. 2014 Jun;63(6):1319-25. doi: 10.1161/HYPERTENSIONAHA.114.03194. Epub 2014 Mar 24.
PubMed 24664290
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Success Rate and Long Term Consequences of Renal Denervation in Patients With Therapy Resistant Hypertension. The Dutch National Renal Denervation Registry
- ClinicalTrials.gov ID
- NCT02482103
- Acronym / sponsor ID
- NL_RDN_REG / NL-RDN_REG
- Conditions
- Hypertension
- Keywords
- Therapy resistant hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- Apr 2013
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Jun 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.
This study is a national registry of patients treated with renal denervation (RD) in the Netherlands.
The aim of the study is to collect data on safety of the procedure, predictors of the blood pressure lowering effect, sustainability of the effect and to assess the cardiovascular event rate in patients treated with renal denervation.
This is a prospective observational study.
Detailed description
Hypertension is common and one of the major risk factors for cardiovascular disease. Therefore, it is a major societal and economic health problem. A substantial proportion (20-40%) of the treated hypertensive patients has sub-optimal blood pressure control despite the use of multiple drugs. All these patients have an increased cardio-vascular risk. Furthermore, the use of multiple drugs diminishes compliance to treatment, and increases the risk of side effects. This underscores the need for new approaches for hypertension management. Elevated (renal) sympathetic nerve activity contributes importantly to the development of hypertension and subsequent vascular risk. Deliberate disruption of sympathetic nerve activity (sympatholytic therapy) leads to improvement of vascular outcome through blood pressure dependent and blood pressure independent effects. Recently, a promising novel sympatholytic approach has been introduced, i.e. catheter-based renal denervation in a small clinical trial with resistant hypertensive patients. Many clinical centres have now started to perform this procedure or are in the process to start up.
The Dutch Minister of Health has decided to allow renal denervation in patients with so called resistant hypertension, and "conditional reimbursement" is available starting Jan 1st 2013 for a maximum of 4 years. The Netherlands Organisation for Health Research and Development (ZonMw) has provided us with a grant to perform a randomized trial (SYMPATHY) to evaluate the effect on blood pressure at 6 months after intervention. Maximum follow-up in this trial will be 2 years. Important limitations of this study are, firstly that that follow-up is limited to 2 years after renal denervation. Secondly, not all patients that undergo renal denervation, will participate in the abovementioned trial. The Dutch National Renal Denervation Registry will complement the information from the trial in several aspects. These deal with safety, non-responders, and sustainability.
Objectives of the national database are to collect data that will deliver information on:
Safety:
- What are the short and long term procedural related complications? Responders
- What are the predictors for the effect on blood pressure, in particular patient related factors and procedural related factors?
- Are there differences between the various renal denervation devices? Sustainability
- What is the effect on blood pressure after (3), 6, (9), 12, (18), 24, (30), 36, and 60 months and thereafter in patients who are considered eligible based on the judgement of the treating physician?
- What is the effect on kidney function after (3), 6, (9), 12, (18), 24, (30), 36, and 60 months and thereafter in patients who are considered eligible based on the judgement of the treating physician?
- What are the cardiovascular events rates in this population, in strata of achieved blood pressure level, and potentially compared with other populations.
Methods:
With this database a nationwide cohort is build comprising patients treated with renal denervation over the years, with uniform baseline data collection and uniform follow-up measurements in terms of safety measurements, blood pressure measurements, hospitalisations, cardiovascular outcomes and all-cause mortality. The data collection will occur through a web-based data entry application. All centers in the Netherlands that perform renal denervation will be asked to participate. All patients who underwent renal denervation should be included, irrespective of the reason and device used.
To address the outstanding research questions specific statistical analyses plans will be applied.
Conclusion:
Our expected results are:
- to be able to identify patients characteristics, which are associated with a high probability of a favourable blood pressure response to renal denervation,
- to provide short-and long-term (24 -60 months) side effects of renal denervation
Perspective:
These results, collected in routine clinical practice in a large number of clinics in the Netherlands, will have a major impact on the treatment of 'resistant hypertension'. The safety and efficacy data will pave the way for formal cost-effectiveness analyses. The data have the potential to be of high relevance to decision and policy makers in the government and health insurances. When deemed cost-effective and safe, this approach will be widely used in the treatment of 'resistant hypertension' and will revolutionise the treatment of these patients. Furthermore, it will open ways for evaluation of other groups of patients characterized by a high sympathetic tone; in particular patients with less severe hypertension, heart failure and chronic kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with renal denervation | – | Procedure: Renal denervationPatients treated with RD in the Netherlands. The decision to perform RD was made by the treating physician in the participating hospitals. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with (or evaluated and refused for) renal denervation in Dutch hospitals. Indications for RD (by Dutch consensus) are therapy resistant hypertension defined as a blood pressure above treatment goal despite use of 3 or more antihypertensive agents preferably including a diuretic or intolerance for (additional) antihypertensives. Secondary hypertension is excluded beforehand.
Key inclusion criteria (1 listed)
- treated with renal denervation. The decision to perform the procedure was made by the treating physician in the participating hospitals
Key exclusion criteria (1 listed)
- below age of 18 years
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 |
|---|---|---|
| Renal denervationCatheter based renal nerve ablation | Procedure or surgery | Patients treated with renal denervation |
Primary outcome
Change in blood pressure
Time frame: 6 months
Change in blood pressure at 6 months
6 secondary outcomes
safety aspects (change in renal function)
Time frame: 5 years
safety aspects: long term kidney function
Time frame: 5 years
longterm consequences: CVD events
Time frame: 5 years
safety aspects: procedures complication
Time frame: 1 year
longterm consequences: kidney function
Time frame: 5 years
longterm consequences: mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Background: PubMed 23610453Vink EE, Bots ML, Blankestijn PJ. Renal denervation as therapy for hypertension: potentials and unanswered questions. Eur J Prev Cardiol. 2013 Dec;20(6):980-91. doi: 10.1177/2047487312473019. Epub 2012 Dec 19.
- Results publication: PubMed 25326543Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M, Leiner T. Effects of renal denervation on end organ damage in hypertensive patients. Eur J Prev Cardiol. 2015 May;22(5):558-67. doi: 10.1177/2047487314556003. Epub 2014 Oct 17.
- Results publication: PubMed 25023158Vink EE, Verloop WL, Bost RB, Voskuil M, Spiering W, Vonken EJ, Bots ML, Blankestijn PJ. The blood pressure-lowering effect of renal denervation is inversely related to kidney function. J Hypertens. 2014 Oct;32(10):2045-53; discussion 2053. doi: 10.1097/HJH.0000000000000282.
- Results publication: PubMed 24931208Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M. Renal denervation in multiple renal arteries. Eur J Clin Invest. 2014 Aug;44(8):728-35. doi: 10.1111/eci.12289.
- Results publication: PubMed 23743806Verloop WL, Vink EE, Voskuil M, Vonken EJ, Rookmaaker MB, Bots ML, Doevendans PA, Blankestijn PJ, Spiering W. Eligibility for percutaneous renal denervation: the importance of a systematic screening. J Hypertens. 2013 Aug;31(8):1662-8. doi: 10.1097/HJH.0b013e328362152e.
- Results publication: PubMed 24664290Persu A, Jin Y, Baelen M, Vink E, Verloop WL, Schmidt B, Blicher MK, Severino F, Wuerzner G, Taylor A, Pechere-Bertschi A, Jokhaji F, Fadl Elmula FE, Rosa J, Czarnecka D, Ehret G, Kahan T, Renkin J, Widimsky J Jr, Jacobs L, Spiering W, Burnier M, Mark PB, Menne J, Olsen MH, Blankestijn PJ, Kjeldsen S, Bots ML, Staessen JA; European Network Coordinating research on REnal Denervation Consortium. Eligibility for renal denervation: experience at 11 European expert centers. Hypertension. 2014 Jun;63(6):1319-25. doi: 10.1161/HYPERTENSIONAHA.114.03194. Epub 2014 Mar 24.
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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.
Michiel Bots, MD, PhD contact
Michiel L. Bots, MD, PhD principal investigator
Julius Center for Health Sciences and Primary Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by UMC Utrecht 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michiel Bots, MD, PhD (m.l.bots@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: 6 months). 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 NCT02482103, which also lists 6 linked publications.
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 2015.