No registrations found.
ID
Source
Brief title
Health condition
Patients with refractory hypertension and patients with combined hypertension and paroxysmal or persistent atrial fibrillation.
Patients who are accepted for renal denervation or combined pulmonary vein isolation and renal denervation according to routine clinical practice are eligible for this study.
Patiënten met refractaire hypertensie en patiënten met gecombineerde hypertensie en paroxysmale of aanhoudende atrim fibrileren.
Patiënten die worden geaccepteerd voor renale denervatie of gecombineerde longaderisolatie met renale denervatie volgens routine klinische praktijk en in aanmerking komen voor deze studie.
Sponsors and support
Intervention
Outcome measures
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
Background 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)
Study objective
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.
Study design
3,6,12 months outcome
Intervention
-RNS-checked RDN
- RNS-guided RDN
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4239 |
| NTR-old | NTR4384 |
| CCMO | NL47172.075.13 |
| OMON | NL-OMON41331 |