NCT02496117

Brief Summary

Study design: Investigator initiated, single centre, feasibility study Main objectives are twofold:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

March 14, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

5.3 years

First QC Date

July 7, 2015

Last Update Submit

May 4, 2020

Conditions

HypertensionRenal Denervation

Outcome Measures

Primary Outcomes (1)

  • 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.

    during procedure

Secondary Outcomes (4)

  • blood pressure at 3 months

    3 months after the intervention

  • blood pressure at 6 months

    6 months after the intervention

  • blood pressure at 12 months

    12 months after the intervention

  • change in blood pressure compared to measurement before the intervention

    intervention - up to 12 months after the intervention

Study Arms (2)

RNS-checked RDN

ACTIVE COMPARATOR

20 patients with hypertension will be enrolled undergoing RNS-checked RDN

Procedure: Electrical mapping, nerve stimulation checked renal denervation procedure

RNS-guided RDN

EXPERIMENTAL

20 patients with hypertension will be enrolled undergoing RNS-guided RDN

Procedure: Electrial mapping, nerve stimulation guided renal denervation procedure

Interventions

Electrical mapping, nerve stimulation checked renal denervation procedurePROCEDURE
Also known as: RNS-checked RDN
RNS-checked RDN
Electrial mapping, nerve stimulation guided renal denervation procedurePROCEDURE
Also known as: RNS-guided RDN
RNS-guided RDN

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A. Elvan

Zwolle, Overijssel, 8025AB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34647513DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
RNS guided RDN
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RNS checked RDN
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

March 14, 2014

Primary Completion

July 4, 2019

Study Completion

July 4, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations

NL(1)