|- candidate number||16172|
|- NTR Number||NTR4384|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jan-2014|
|- Secondary IDs||NL47172.075.13 |
|- Public Title||Feasibility of electrical mapping and stimulation of renal arteries in patients undergoing renal denervation|
|- Scientific Title||Feasibility of electrical mapping and stimulation of renal arteries in patients undergoing renal denervation|
|- ACRONYM||Renal Nerves Stimulation (RNS) Study|
|- hypothesis|| 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 renal nerve stimulation (RNS)-guided renal denervation (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.
|- Healt Condition(s) or Problem(s) studied||Hypertension|
|- Inclusion criteria||- Patients with refractory hypertension and patients with combined hypertension and paroxysmal or persistent atrial fibrillation. |
- Age 18-80 years
- Glomerularfiltrationrate >45 mL/min
- No history of renal artery stenosis
|- Exclusion criteria||- Type 1 diabetes mellitus|
- Contraindication to chronic anticoagulation therapy or heparin.
- Primary pulmonary hypertension.
- Known secondary cause of hypertension
- Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ¡Ü3 mm.
- Dual or triple ipsilateral renal artery ostia.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-dec-2018|
|- Target number of participants||40|
|- Interventions||-RNS-checked RDN|
- RNS-guided RDN
|- Primary outcome||Main study parameter will be the arterial blood pressure response to renal nerve stimulation (RNS) prior to renal denervation (RDN) and absence of blood pressure rise in response to pacing in the renal artery after renal denervation (RDN).
|- Secondary outcome||Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
|- Timepoints||3,6,12 months outcome|
|- Trial web site||no|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Sonja Postma|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A. Elvan|
|- Sponsor/Initiator ||Isala Hospital, Department of Cardiology|
(Source(s) of Monetary or Material Support)
|Isala Hospital, Department of Cardiology|
|- Brief 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)
|- Main changes (audit trail)|
|- RECORD||23-jan-2014 - 26-jun-2017|