Arrhythmias, CardiacPhase 2Redress VTNCT02856373
Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias
A Phase 2 study testing RNS and RDN in people with Arrhythmias, Cardiac, run by Diagram B.V. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- RNS and RDN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Mar 2015to 4 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- The patient falls within the target group as stated in 4.1.
- Patient is an acceptable candidate for RDN treatment
- Patient is 18-85 years of age
- Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)
Who cannot join
- Contraindication to anticoagulation therapy or heparin.
- Previous selective cardiac sympathetic denervation or previous RDN 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).
Show all 13Show fewer
- Enrolment in another investigational drug or device study.
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
- Mental or physical inability to participate in the study.
- Planned cardiovascular intervention.
- Life expectancy ≤ 12 months.
- Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm.
- Complex renal artery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias: an Investigator Initiated Trial
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.
Read more
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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- RNS and RDN
- Keywords
- Denervation, Renal Artery
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS and RDNProcedure or surgery
The patients will undergo electrical renal nerve stimulation and subsequently renal nerve denervation
| Study group | Role | What they receive |
|---|---|---|
| CPVT | Other | catecholaminergic polymorphic ventricular tachycardia (CPVT) patients Receives: Procedure: RNS and RDN |
| long QT syndrome | Other | long QT syndrome patients Receives: Procedure: RNS and RDN |
| ARVC | Other | arrhythmogenic right ventricular cardiomyopathy (ARVC) patients Receives: Procedure: RNS and RDN |
| HCM | Other | hypertrophic cardiomyopathy (HCM) patients Receives: Procedure: RNS and RDN |
| DCM | Other | dilated non-ischemic cardiomyopathy (DCM) patients Receives: Procedure: RNS and RDN |
| ICM | Other | ischemic cardiomyopathy (ICM) patients Receives: Procedure: RNS and RDN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of ventricular arrhythmias (e.g. ventricular tachycardia and ventricular fibrillation)
Induction of ventricular arrhythmias in response to RNS prior to RDN and absence of RNS induced ventricular arrhythmias after RDN
Measured: 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.
Development of ventricular arrhythmia
Development of ventricular arrhythmia during exercise stress testing performed 6 months after procedure/intervention
Measured: 6 months after procedure/intervention
Secondary outcomes (14)
Time to first detection of ventricular arrhythmia or appropriate ICD therapy
Time to first detection of ventricular arrhythmia or appropriate ICD therapy with the monitoring period starting immediately after the intervention.
Measured: procedure/intervention-12 month follow up
Changes in ventricular refractoriness (frequency)
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.
Measured: procedure/intervention
Changes in ventricular refractoriness (duration)
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.
Measured: procedure/intervention
Number of ventricular arrhythmias
Inducibility (number) of ventricular arrhythmias to programmed electrical stimulation in the setting of routine electrophysiological study before and after RDN.
Measured: procedure/intervention
Ventricular arrhythmia burden
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.
Measured: procedure/intervention- 6,12 months follow up
Blood pressure
Blood pressure at 6 and 12 months after the intervention
Measured: 6-12 months follow up
Number of (Supra-)Ventricular arrhythmias induced by exercise testing
Number of (Supra-)Ventricular arrhythmias induced by exercise testing
Measured: baseline- 6 months follow up
(Supra-)Ventricular arrhythmias response changes (frequency) induced by exercise testing
(Supra-)Ventricular arrhythmias response changes (frequency, beats/min) induced by exercise testing
Measured: baseline- 6 months follow up
(Supra-)Ventricular arrhythmias response changes (duration) induced by exercise testing
(Supra-)Ventricular arrhythmias response changes (duration, sec) induced by exercise testing
Measured: baseline- 6 months follow up
Changes in heart rate variability
Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention
Measured: baseline- 3, 6 and 12 month follow up
Changes in prevalence of events
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.
Measured: 12 month before procedure/intervention-12 month follow up
Change in blood pressure
Change in blood pressure compared to measurement before the intervention
Measured: baseline- 6, 12 month follow up
Heart rate response changes induced by exercise testing
Heart rate response changes induced by exercise testing
Measured: baseline- 6 months follow up
Blood pressure response changes induced by exercise testing
Blood pressure response changes induced by exercise testing
Measured: baseline-6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start3 Mar 2015
- Primary completion4 May 2020
- Study completion4 May 2020
Why it stopped: Low enrollment number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Elvan, MD, PhD, Principal investigator, Isala, department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856373
- Sponsor's protocol ID
- 9218
- Acronym
- Redress VT
- Status last verified
- May 2020
- First submitted
- 10 Jun 2016
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias: an Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT02856373
- Acronym / sponsor ID
- Redress VT / 9218
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Denervation, Renal Artery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment number
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CPVT | Other | Procedure: RNS and RDNcatecholaminergic polymorphic ventricular tachycardia (CPVT) patients |
| long QT syndrome | Other | Procedure: RNS and RDNlong QT syndrome patients |
| ARVC | Other | Procedure: RNS and RDNarrhythmogenic right ventricular cardiomyopathy (ARVC) patients |
| HCM | Other | Procedure: RNS and RDNhypertrophic cardiomyopathy (HCM) patients |
| DCM | Other | Procedure: RNS and RDNdilated non-ischemic cardiomyopathy (DCM) patients |
| ICM | Other | Procedure: RNS and RDNischemic cardiomyopathy (ICM) patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- The patient falls within the target group as stated in 4.1.
- Patient is an acceptable candidate for RDN treatment
- Patient is 18-85 years of age
- Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)
Key exclusion criteria (13 listed)
- Contraindication to anticoagulation therapy or heparin.
- Previous selective cardiac sympathetic denervation or previous RDN 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNS and RDNThe patients will undergo electrical renal nerve stimulation and subsequently renal nerve denervation | Procedure or surgery | ARVC, CPVT, DCM, HCM, ICM, long QT syndrome |
Primary outcome
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
14 secondary outcomes
Time to first detection of ventricular arrhythmia or appropriate ICD therapy
Time frame: procedure/intervention-12 month follow up
Changes in ventricular refractoriness (frequency)
Time frame: procedure/intervention
Changes in ventricular refractoriness (duration)
Time frame: procedure/intervention
Number of ventricular arrhythmias
Time frame: procedure/intervention
Ventricular arrhythmia burden
Time frame: procedure/intervention- 6,12 months follow up
Blood pressure
Time frame: 6-12 months follow up
Number of (Supra-)Ventricular arrhythmias induced by exercise testing
Time frame: baseline- 6 months follow up
(Supra-)Ventricular arrhythmias response changes (frequency) induced by exercise testing
Time frame: baseline- 6 months follow up
(Supra-)Ventricular arrhythmias response changes (duration) induced by exercise testing
Time frame: baseline- 6 months follow up
Changes in heart rate variability
Time frame: baseline- 3, 6 and 12 month follow up
Changes in prevalence of events
Time frame: 12 month before procedure/intervention-12 month follow up
Change in blood pressure
Time frame: baseline- 6, 12 month follow up
Heart rate response changes induced by exercise testing
Time frame: baseline- 6 months follow up
Blood pressure response changes induced by exercise testing
Time frame: baseline-6 months follow up
Results and safety
The study was stopped early (reason given: Low enrollment number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
Related trials for Arrhythmias, Cardiac
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Elvan, MD, PhD principal investigator
Isala, department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNS and RDN in people with Arrhythmias, Cardiac, run by Diagram B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment number). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.