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Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias (Redress VT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02856373
Recruitment Status : Terminated (Low enrollment number)
First Posted : August 4, 2016
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Diagram B.V.

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE March 3, 2015
Actual Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Induction of ventricular arrhythmias (e.g. ventricular tachycardia and ventricular fibrillation) [ Time Frame: A few minutes before RDN RNS will be performed. Time frame before RDN: 0-10 min. after RNS and before RDN. Time frame after RDN: 0-10 min. ]
    Induction of ventricular arrhythmias in response to RNS prior to RDN and absence of RNS induced ventricular arrhythmias after RDN
  • Development of ventricular arrhythmia [ Time Frame: 6 months after procedure/intervention ]
    Development of ventricular arrhythmia during exercise stress testing performed 6 months after procedure/intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Time to first detection of ventricular arrhythmia or appropriate ICD therapy [ Time Frame: procedure/intervention-12 month follow up ]
    Time to first detection of ventricular arrhythmia or appropriate ICD therapy with the monitoring period starting immediately after the intervention.
  • Changes in ventricular refractoriness (frequency) [ Time Frame: procedure/intervention ]
    Changes in ventricular refractoriness (frequency, beats/min) to programmed electrical stimulation in the setting of routine electrophysiological study before and directly (0-10 min) after RDN.
  • Changes in ventricular refractoriness (duration) [ Time Frame: procedure/intervention ]
    Changes in ventricular refractoriness (duration, sec) to programmed electrical stimulation in the setting of routine electrophysiological study before and directly (0-10 min) after RDN.
  • Number of ventricular arrhythmias [ Time Frame: procedure/intervention ]
    Inducibility (number) of ventricular arrhythmias to programmed electrical stimulation in the setting of routine electrophysiological study before and after RDN.
  • Ventricular arrhythmia burden [ Time Frame: procedure/intervention- 6,12 months follow up ]
    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 [ Time Frame: 6-12 months follow up ]
    Blood pressure at 6 and 12 months after the intervention
  • Number of (Supra-)Ventricular arrhythmias induced by exercise testing [ Time Frame: baseline- 6 months follow up ]
    Number of (Supra-)Ventricular arrhythmias induced by exercise testing
  • (Supra-)Ventricular arrhythmias response changes (frequency) induced by exercise testing [ Time Frame: baseline- 6 months follow up ]
    (Supra-)Ventricular arrhythmias response changes (frequency, beats/min) induced by exercise testing
  • (Supra-)Ventricular arrhythmias response changes (duration) induced by exercise testing [ Time Frame: baseline- 6 months follow up ]
    (Supra-)Ventricular arrhythmias response changes (duration, sec) induced by exercise testing
  • Changes in heart rate variability [ Time Frame: baseline- 3, 6 and 12 month follow up ]
    Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention
  • Changes in prevalence of events [ Time Frame: 12 month before procedure/intervention-12 month follow up ]
    Changes in prevalence of events (hospital admission for VT or appropriate ICDshock) in the period of one year after intervention compared to a one year period before intervention.
  • Change in blood pressure [ Time Frame: baseline- 6, 12 month follow up ]
    Change in blood pressure compared to measurement before the intervention
  • Heart rate response changes induced by exercise testing [ Time Frame: baseline- 6 months follow up ]
    Heart rate response changes induced by exercise testing
  • Blood pressure response changes induced by exercise testing [ Time Frame: baseline-6 months follow up ]
    Blood pressure response changes induced by exercise testing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias
Official Title  ICMJE Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias: an Investigator Initiated Trial
Brief Summary

Rationale:

Sympathetic activity plays an important role in the pathogenesis of ventricular tachyarrhythmia. 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. The investigators hypothesize that percutaneous transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in patients with sympathetic ventricular arrhythmias.

Objective:

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 catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic effects of RDN in patients with sympathetic ventricular tachy-arrhythmias.

Study design:

Investigator initiated, multi centre, six pretest-posttest design studies.

Study population:

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 18-85 year.

Intervention:

RDN will be performed according to routine clinical practice. Prior to the ablation procedure, catheter mapping of the renal arteries will be performed according to routine clinical practice. Clinical and biological responses to transluminal electrical renal nerve stimulation will be assessed before and after RDN.

Study endpoints:

  • Main procedural study endpoint: Induction of ventricular arrhythmias in response to renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced ventricular arrhythmias after RDN.
  • Main clinical study endpoint: Development of ventricular arrhythmia during exercise stress testing performed 6 months after procedure.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

In several studies, it was shown that RDN was safe. The intervention resulted in significantly better control of blood pressure with less medication, and beneficial changes in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a higher success of atrial fibrillation prevention. In case reports and case series, RDN had a favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arrhythmias, Cardiac
Intervention  ICMJE Procedure: RNS and RDN
The patients will undergo electrical renal nerve stimulation and subsequently renal nerve denervation
Study Arms  ICMJE
  • CPVT
    catecholaminergic polymorphic ventricular tachycardia (CPVT) patients
    Intervention: Procedure: RNS and RDN
  • long QT syndrome
    long QT syndrome patients
    Intervention: Procedure: RNS and RDN
  • ARVC
    arrhythmogenic right ventricular cardiomyopathy (ARVC) patients
    Intervention: Procedure: RNS and RDN
  • HCM
    hypertrophic cardiomyopathy (HCM) patients
    Intervention: Procedure: RNS and RDN
  • DCM
    dilated non-ischemic cardiomyopathy (DCM) patients
    Intervention: Procedure: RNS and RDN
  • ICM
    ischemic cardiomyopathy (ICM) patients
    Intervention: Procedure: RNS and RDN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 4, 2020)
9
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
60
Actual Study Completion Date  ICMJE May 4, 2020
Actual Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient is willing and able to comply with the protocol and has provided written informed consent.
  2. The patient falls within the target group as stated in 4.1.
  3. Patient is an acceptable candidate for RDN treatment
  4. Patient is 18-85 years of age
  5. Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)

Exclusion Criteria:

  1. Contraindication to anticoagulation therapy or heparin.
  2. Previous selective cardiac sympathetic denervation or previous RDN procedure.
  3. Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment.
  4. Untreated hypothyroidism or hyperthyroidism.
  5. More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe).
  6. Severe LV dysfunction (LVEF <20% and/or grade 3/4 diastolic dysfunction).
  7. Enrolment in another investigational drug or device study.
  8. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
  9. Mental or physical inability to participate in the study.
  10. Planned cardiovascular intervention.
  11. Life expectancy ≤ 12 months.
  12. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm.
  13. Complex renal artery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02856373
Other Study ID Numbers  ICMJE 9218
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diagram B.V.
Study Sponsor  ICMJE Diagram B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arif Elvan, MD, PhD Isala, department of Cardiology
PRS Account Diagram B.V.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP