Renal Nerves Stimulation Study
Condition: Hypertension; Renal Denervation
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

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. 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:

        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. 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:

        1. RNS-checked RDN

        2. 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.
    

Intervention name(s): Electrical mapping, nerve stimulation checked renal denervation procedure; Electrial mapping, nerve stimulation guided renal denervation procedure
Intervention type(s): Procedure; Procedure
Other intervention name(s): RNS-checked RDN; RNS-guided RDN
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: RNS checked RDN
Masking: None (Open Label)
Primary purpose: Treatment