The Dutch National Renal Denervation Registry
NL_RDN_REG
Safety, Success Rate and Long Term Consequences of Renal Denervation in Patients With Therapy Resistant Hypertension. The Dutch National Renal Denervation Registry
1 other identifier
observational
1,000
1 country
1
Brief 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 renal denervation. This is a prospective observational study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJune 26, 2015
June 1, 2015
6 years
June 11, 2015
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in blood pressure
Change in blood pressure at 6 months
6 months
Secondary Outcomes (6)
safety aspects (change in renal function)
5 years
safety aspects: long term kidney function
5 years
longterm consequences: CVD events
5 years
safety aspects: procedures complication
1 year
longterm consequences: kidney function
5 years
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Catheter based renal nerve ablation
Eligibility Criteria
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.
You may qualify if:
- treated with renal denervation. The decision to perform the procedure was made by the treating physician in the participating hospitals
You may not qualify if:
- below age of 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Dutch Kidney Foundationcollaborator
Study Sites (1)
UMC Utrecht
Utrecht, Netherlands
Related Publications (6)
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.
PMID: 23610453BACKGROUNDVerloop 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.
PMID: 25326543RESULTVink 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.
PMID: 25023158RESULTVerloop 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.
PMID: 24931208RESULTVerloop 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.
PMID: 23743806RESULTPersu 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.
PMID: 24664290RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michiel L. Bots, MD, PhD
Julius Center for Health Sciences and Primary Care
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Epidemiology of Cardiovascular Disease
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 26, 2015
Study Start
April 1, 2013
Primary Completion
April 1, 2019
Study Completion
April 1, 2020
Last Updated
June 26, 2015
Record last verified: 2015-06