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…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
central autonomic nervous system
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Induction of ventricular arrhythmias in response to renal nerve stimulation
prior to renal denervation and absence of ventricular arrhythmias in response
to renal nerves stimulation after renal denervation.
Induction of ventricular arrhythmia during exercise stress testing performed 6
months after renal denervation.
Secondary outcome
Time to first detection of ventricular arrhythmia or appropriate ICD therapy
with the monitoring period starting immediately after the intervention.
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.
Time to first detection of ventricular arrhythmia or appropriate ICD therapy,
with the monitoring period starting immediately after the intervention.
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.
Blood pressure at 6 and 12 months after the intervention, and change in blood
pressure compared to measurement before the intervention
(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.
Changes in prevalence of events (hospital admission for VT or appropriate
ICD-shock) in the period of one year after intervention compared to a one year
period before intervention.
Background summary
Sympathetic activity plays an important role in the pathogenesis of ventricular
tachyarrhythmia. Emotional, physiological and physical stress is associated
with increased rates of sudden cardiac death. Previous studies have shown
evidence of significant heritable influences on individual responses to
adrenergic stimulation. Catheter-based renal sympathetic denervation (RDN) is a
novel treatment option for patients with resistant hypertension, proved to
reduce local and whole-body sympathetic activity. This study will focus on
patients with sympathetically driven ventricular tachy-arrhythmias in the
setting of catecholaminergic polymorphic ventricular tachycardia (CPVT), long
QT syndrome, arrhythmogenic right ventricular cardiomyopathy (ARVC),
hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM)
and ischemic cardiomyopathy (ICM).
Heritable cardiac diseases associated with ventricular tachy-arrhythmias such
as CPVT and long QT syndrome are characterized by episodic palpitations and/or
(near-) syncope occurring during exercise or acute emotion in individuals
without structural cardiac abnormalities.
ARVC is an acronym for a genetically heterogeneous group of cardiomyopathies,
characterised by structural and functional abnormalities of the right and left
ventricle. ARVC patients usually present with ventricular arrhythmias and in
advanced stages heart failure may occur. Ventricular arrhythmias in ARVC
patients is often associated with physical exercise. Anti-arrhythmic medication
is not effective in selected patients with symptomatic ARVC and histories of
ventricular arrhythmia or cardiac arrest. In asymptomatic ARVC gene carriers
sudden cardiac death may be the first clinical manifestation.
HCM is a genetic cardiomyopathy characterized by abnormal thickening of the
ventricular wall, which may lead to obstruction of the left ventricular outflow
tract (LVOT). Patients may be asymptomatic, but may experience breathlessness
due to obstruction of the LVOT. HCM is also a predisposition to ventricular
arrhythmia. The ventricular arrhythmias may even continue despite surgical
treatment of HCM by myotomy.
DCM is a type of cardiomyopathy characterized by a global weakness of the
cardiac muscle with dilating of the left ventricle resulting in heart failure.
Coronary artery disease has been excluded in these patients to differentiate
DCM from ICM.
ICM is a type of cardiomyopathy induced by ischemic events like acute coronary
syndromes or the global diminished ventricular function due to three vessel
disease warranting coronary artery bypass graft surgery. What these
cardiomyopathies have in common is an increased incidence of ventricular
arrhythmia. In patients with a left ventricular ejection fraction (LVF) of <35%
a ICD is indicated. Some patients present with therapy refractory ventricular
arrhythmia despite optimal medical therapy. In a small case series with 2
ischemic and 2 non-ischemic cardiomyopathy RDN was added to VT ablation. This
small series has shown benefit of RDN on top of VT ablation. Not much is known
of the anti-arrhythmic effect of RDN without VT ablation in these types of
patients.
Study objective
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, HCM, DCM or ICM.
The aim of the six studies is to assess the anti-arrhythmic effects of renal
denervation in patients with sympathetic vetricular tachy-arrhythmias in a
controlled fashion.
Study design
Investigator initiated, multi centre, pretest-posttest designed study.
Intervention
Renal denervation is a safe therapy for therapy resistent hypertension.
Succesrate is more than 80% as treatment for therapy resistant hypertension.
Complication risk is <1%. Renal denervation is performed with patients with
"drug refractory" sympatic ventricular arrhythmia, with positive results
described in publications. No randomised controlled studies concerning RDN with
patients with sympathetic ventricular arrhythmia have been done yet.
Study burden and risks
We expect that RDN is successful in preventing sympathetic ventricular
arrhythmia in drug refractory patients, and that the addition of RDN to optimal
pharmacological therapy will be effective in the prevention of sympathetic
ventricular arrhythmias.
Dokter Heesweg 2
Zwolle 8025 AB
NL
Dokter Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Patients with recurrent sympathetic ventricular arrhythmia despite optimal pharmacological therapy.
Patients with CPVT or certain types of long QT syndrome, ARVC, HCM, DCM or ICM. Patients should use adequate beta-blocker dose or should be intolerant for anti-arrhythmic medication.
Patient is an acceptable candidate for renal denervation treatment
Patient is 18-85 years of age
Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)
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 enrolment.
Untreated hypothyroidism or hyperthyroidism.
More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe).
Severe LV dysfunction (LVEF <20% and/or grade 3/4 diastolic dysfunction)
Planned cardiovascular intervention.
Renal artery stenosis >50% of the arterial lumen, or renal artery lumen <=3 mm.
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 | NCT02856373 |
| CCMO | NL47301.075.13 |
| OMON | NL-OMON24558 |