|- candidate number||16288|
|- NTR Number||NTR4385|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2014|
|- Secondary IDs||NL47301.075.13 |
|- Public Title||Renal Nerve Stimulation and renal Denervation in Patients with sympathetic Ventricular Arrhytmias.|
|- Scientific Title||Renal Nerve Stimulation and renal Denervation in Patients with sympathetic Ventricular Arrhytmias.|
|- ACRONYM||Redress VT|
|- hypothesis||This study wil investigate the effects of renal nerve stimulation before and after percutaneous transluminal renal denervation on cardiac excitable properties including induction of ventricular tachy-arrhytmias before and after renal denervation in 3 studies, i.e. patients with CPVT, long QTsyndrome and ARVC and refractory ventricular arrhythmias. The aim of this study is to asses te anti-arrhythmic effects of renal denervation (RDN group) compared to optimal medical therapy (control group) in these 3 studies of patients with sympathetic ventricular tachy-arrhytmias in randomized controlled fashion.|
|- Healt Condition(s) or Problem(s) studied|| Sympathetic ventricular arhythmais|
|- Inclusion criteria||Patients with recurrent sympathetic ventricular arrhytmia, patients with CPVT or long QT syndrome or ARVC. Patients acceptable for renal denervation treatment. Patient is 18-65 years of age. Documentation of ventricular arrhytmia.|
|- Exclusion criteria||Contraindication to anticoagulation therapy or heparin.
Previous selective cardiac sympathetic denervation or previous renal denervation procedure.
Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrollment Untreated hypothyroidism or hyperthyroidism. More than grade 1/3 valvular regurgitation and/or signifant valve stenosis. Severe LV dysfunction. Planned cardiovascular intervention. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen< 3 mm|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2014|
|- planned closingdate||1-jan-2023|
|- Target number of participants||60|
|- Interventions||Renal artery mapping and renal denervation:
A. Catheter mapping of renal arteries and the renal sympathetic nerve distribution with fluoroscopic and nonfluoroscopic 3D navigation systems (Philips EP Navigator and St Jude Ensite Velocity systems) in patients with sympathetic ventricular arrhythmias.Clinical and biological responses of transluminal electrical renal nerve stimulation performed at different segments of each artery. We speculate that ventricular arrhythmias will occur in response to sympathetic nerve stimulation in the renal arteries and after renal denervation this response will be diminished or abolished.
B. Renal denervation ablation sites will be identified with electrical mapping and renal denervation will be guided by the pacing maneuvers in patients with drug refractory sympathetic ventricular arrhythmias.
|- Primary outcome||-Main procedural study endpoint will be: Induction of ventricular arrhythmias in response to renal nerve stimulation prior to renal denervation and absence of renal nerves stimulation induced ventricular arrhythmias after renal denervation.|
-Main clinical study endpoint will be: development of ventricular arrhythmia during exercise stress testing performed 6 months after randomization.
|- Secondary outcome||1. Time to first detection of ventricular arrhythmia or appropriate ICD therapy with the monitoring period starting immediately after the intervention.|
2. Changes in ventricular refractoriness and inducibility of ventricular arrhythmias to programmed electrical stimulation in the setting of routine electrophysiological study before and after renal denervation.
3. Time to first detection of ventricular arrhythmia or appropriate ICD therapy, with the monitoring period starting immediately after the intervention and after randomisation in control group.
4. Ventricular arrhythmia burden after 6 and 12 months of follow-up in patients with ICD or continuous rhythm monitoring with a loop recorder. The monitoring period starts immediately after the intervention in the RDN group and after randomization in the control group.
5. Blood pressure at 6 and 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
6. (Supra-)Ventricular arrhythmias, heart rate and blood pressure response changes induced by exercise testing
Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention.
|- Timepoints||6 months, 12 months|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Sonja Postma|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A. Elvan|
|- Sponsor/Initiator ||Isala Clinics Zwolle|
(Source(s) of Monetary or Material Support)
|- Brief summary||This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal renal denervation on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after renal denervation in six studies, i.e. patients with CPVT, long QT syndrome, ARVC and refractory ventricular arrhythmias, HCM, DCM or ICM. The aim of this study is to assess the anti-arrhythmic effects of RDN in six studies of patients with sympathetic ventricular tachy-arrhythmias.
|- Main changes (audit trail)||14-feb-2016: |
Hypothese NEW: This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal RDN on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with CPVT, long QT syndrome, ARVC and refractory ventricular arrhythmias, HCM, DCM or ICM. The aim of this study is to assess the anti-arrhythmic effects of RDN in six studies of patients with sympathetic ventricular tachy-arrhythmias.
Inclusion criteria NEW: Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-65 year.
3rd outcome is similar to the 1st, so will be deleted.
METC Isala Zwolle amendement 5:
Inclusion criteria NEW:
- Eligible patients will be in the age category of 18-85 year
|- RECORD||30-jan-2014 - 29-apr-2017|