The Dutch National Renal Denervation Registry (NL_RDN_REG)

June 25, 2015 updated by: Michiel L. Bots, UMC Utrecht

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. What are the short and long term procedural related complications?

    Responders

  2. What are the predictors for the effect on blood pressure, in particular patient related factors and procedural related factors?

  3. Are there differences between the various renal denervation devices?

    Sustainability

  4. 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?
  5. 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?
  6. 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:

  1. to be able to identify patients characteristics, which are associated with a high probability of a favourable blood pressure response to renal denervation,
  2. 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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • treated with renal denervation. The decision to perform the procedure was made by the treating physician in the participating hospitals

Exclusion Criteria:

  • below age of 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Renal denervation
Catheter based renal nerve ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: 6 months
Change in blood pressure at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety aspects (change in renal function)
Time Frame: 5 years
change in renal function
5 years
safety aspects: long term kidney function
Time Frame: 5 years
change in renal function
5 years
longterm consequences: CVD events
Time Frame: 5 years
cardiovascular event rates
5 years
safety aspects: procedures complication
Time Frame: 1 year
procedural complications
1 year
longterm consequences: kidney function
Time Frame: 5 years
change in kidney function
5 years
longterm consequences: mortality
Time Frame: 5 years
mortality
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Dutch Kidney Foundation

Investigators

  • Principal Investigator: Michiel L. Bots, MD, PhD, Julius Center for Health Sciences and Primary Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-RDN_REG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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