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…
ID
Source
Brief title
Condition
- Other condition
- Vascular hypertensive disorders
Synonym
Health condition
central autonomic nervous system
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Blood pressure at 3, 6, 12 months after the intervention, and change in blood
pressure compared to measurement before the intervention.
Background summary
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, renal denervation 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.
Study objective
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.
Study design
Investigator initiated, single centre, prospective, feasibility study
Study burden and risks
A total number of 40 patients will be included. Twenty patients will be treated
with the RNS-checked RDN procedure and 20 patients will be treated with the
RNS-guided RDN procedure.
Based on clinical experience, we expect that 40 patients will be sufficient to
provide data on the abovementioned aims and endpoints.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Patients with refractory hypertension
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 <=3 mm
Dual or triple ipsilateral renal artery ostia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02496117 |
| CCMO | NL47172.075.13 |
| OMON | NL-OMON28437 |