HypertensionPhase 3NCT02346045
Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension
A Phase 3 study testing Renal sympathetic denervation in people with Hypertension, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
Trial summary
A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have been developed to treat hypertension properly and reduce cardiovascular risk. B. However, there is a subgroup of hypertension which are resistant to treatment. 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal sympathetic denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Sep 2014to Oct 2018
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are under hemodialysis due to end stage renal disease
- Patients who have resistant hypertension with office SBP >160 mmHg)
- Patients who are or over 18 years old.
- Patients who submit informed consent
Who cannot join
- Known secondary hypertension patients
- Patients who have renal artery which is not adequate for renal denervation
- The main renal artery diameter < 4 mm, or renal artery length < 20 mm
- The renal arteries into which stable catheter insertion is difficulty and which have hemodynamically or anatomically significant stenosis
- The renal arteries who have undergone renal angioplasty
- Patients who have history of myocardial infarction, unstable angina, syncope cerebrovascular insufficiency or extensive atherosclerotic disease with intravascular thrombosis, or unstable plaque
Show all 18Show fewer
- Type 1 Diabetes
- Patients who have scheduled percutaneous coronary intervention (PCI) or operation within 6 months
- Hemodynamically significant valvular heart disease in which blood pressure reduction may cause significant deterioration of patient's health.
- Primary pulmonary hypertension
- Patients who have the intracardiac defibrillator(ICD) or pacemaker which do not allow delivery of radiofrequency energy.
- Patients who require continuous oxygen supply or mechanical ventilation for treatment of obstructive sleep apnea
- Patients who have serious medical condition which can compromise the safety of the patients and the safety and integrity of the study.
- Patients who have unresolved drug issue, alcoholism
- Patients who lack ability to understand and follow the instruction the researcher
- Patient who cannot follow up
- Patients who are registered in other trial
- Patients who are pregnant, nursing or planning to be pregnant
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Daejon St. Mary's Hospital
Daejeon, Chungchung Nam Do, 301-723
Sung Ho Her, MD, PhD, +8242-220-9686, hhhsungho@hanmail.net
Chan Joon Kim, MD
- Recruiting
Chungnam National University
Daejeon, Chungchungnamdo, 301-721
Jin Ok Jung
- Recruiting
Pohang St. Mary's Hospital
Pohang, Kyungsangnamdo, 790-825
Seung Jae Lee, MD
- Recruiting
Seoul St. Mary's Hospital
Seoul, Seoul, 137-701
Kiyuk Chang, MD, PhD, +822-2258-1139, kiyuk@catholic.ac.kr
Yoon- Seok Koh
About this study
Official title: Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea
- Hypertension is a major cardiovascular risk factor and numerous treatment strategies have been developed to treat hypertension properly and reduce cardiovascular risk.
- However, there is a subgroup of hypertension which are resistant to treatment.
- Resistant hypertension is associated to sympathetic hyperactivity
- Renal sympathetic nerve is known to be associated with systemic sympathetic activity
- According to research of recent years, catheter based renal sympathetic denervation is a safe and effective treatment modality to treat resistant hypertension C. Resistant hypertension is observed in end stage renal disease (ESRD) frequently.
- Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic denervation is expected to improve resistant hypertension in ESRD patients
- The aim the present study is to evaluate the effects and safety of catheter based renal sympathetic denervation on resistant hypertension in ESRD
- Conditions
- Hypertension
- Being tested
- Renal sympathetic denervation
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationProcedure or surgery
Also called Catheter based based renal sympathetic denervation, Symplicity catheter system by Medtronic
In the experimental arm, Intervention is renal sympathetic denervation using Symplicity® system (Medtronic Ardian Inc, Mountain View, CA, USA) and antihypertensive medications previously prescribed
- After femoral puncture guiding catheter is engaged in renal artery
- Symplicity radiofrequency ablation catheter is inserted into renal artery and by circular sequence, from distal to proximal portion, ablation energy is applied to the wall of renal artery
- 4-5 ablations are applied in each renal artery.
In the sham comparator, intervention is renal angiogram and continue antihypertensive medications previuosly decribed
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Experimental | Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed) Receives: Procedure: Renal sympathetic denervation |
| Medical therapy | Sham comparator | renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed) Receives: Procedure: Renal sympathetic denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of office systolic blood pressure after renal denervation
Measured: 6 month
Secondary outcomes (4)
Change of office diastolic blood pressure
Measured: 6 month
change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability
Measured: 6 month
Change in plasma norepinephrine
Measured: 6 months
Change in pulse wave velocity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD., Daiichi Sankyo Korea Co., Ltd.
- Responsible party
- Principal investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Kiyuk Chang, MD, PhD, Principal investigator, Seoul St. Mary's HospitalSung Ho Her, MD, PhD, Principal investigator, Daejon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346045
- Sponsor's protocol ID
- XC13EIMV0110D
- Other IDs
- RDN-ESRD-CMC-01
- Status last verified
- Jan 2015
- First submitted
- 21 Oct 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Bohm M, Lambert EA, Krum H, Sobotka PA, Schmieder RE, Ika-Sari C, Eikelis N, Straznicky N, Lambert GW, Esler MD. Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with end-stage renal disease. Int J Cardiol. 2013 Oct 3;168(3):2214-20. doi: 10.1016/j.ijcard.2013.01.218. Epub 2013 Feb 28.
PubMed 23453868Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880.
PubMed 23248063Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
PubMed 21403086
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea
- ClinicalTrials.gov ID
- NCT02346045
- Acronym / sponsor ID
- XC13EIMV0110D
- Conditions
- Hypertension
- Keywords
- hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD., Daiichi Sankyo Korea Co., Ltd.
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Jan 2015 (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.
- Hypertension is a major cardiovascular risk factor and numerous treatment strategies have been developed to treat hypertension properly and reduce cardiovascular risk.
- However, there is a subgroup of hypertension which are resistant to treatment.
- Resistant hypertension is associated to sympathetic hyperactivity
- Renal sympathetic nerve is known to be associated with systemic sympathetic activity
- According to research of recent years, catheter based renal sympathetic denervation is a safe and effective treatment modality to treat resistant hypertension C. Resistant hypertension is observed in end stage renal disease (ESRD) frequently.
- Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic denervation is expected to improve resistant hypertension in ESRD patients
- The aim the present study is to evaluate the effects and safety of catheter based renal sympathetic denervation on resistant hypertension in ESRD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Experimental | Procedure: Renal sympathetic denervationRenal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed) |
| Medical therapy | Sham comparator | Procedure: Renal sympathetic denervationrenal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are under hemodialysis due to end stage renal disease
- Patients who have resistant hypertension with office SBP >160 mmHg)
- Patients who are or over 18 years old.
- Patients who submit informed consent
Key exclusion criteria (18 listed)
- Known secondary hypertension patients
- Patients who have renal artery which is not adequate for renal denervation
- Patients who have history of myocardial infarction, unstable angina, syncope cerebrovascular insufficiency or extensive atherosclerotic disease with intravascular thrombosis, or unstable plaque
- Type 1 Diabetes
- Patients who have scheduled percutaneous coronary intervention (PCI) or operation within 6 months
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 |
|---|---|---|
| Renal sympathetic denervationAlso: Catheter based based renal sympathetic denervation, Symplicity catheter system by MedtronicIn the experimental arm, Intervention is renal sympathetic denervation using Symplicity® system (Medtronic Ardian Inc, Mountain View, CA, USA) and antihypertensive medications previously prescribed 1. After femoral puncture guiding catheter is engaged in renal artery 2. Symplicity radiofrequency ablation catheter is inserted into renal artery and by circular sequence, from distal to proximal portion, ablation energy is applied to the wall of renal artery 3. 4-5 ablations are applied in each renal artery. In the sham comparator, intervention is renal angiogram and continue antihypertensive medications previuosly decribed | Procedure or surgery | Medical therapy, Renal sympathetic denervation |
Primary outcome
The change of office systolic blood pressure after renal denervation
Time frame: 6 month
4 secondary outcomes
Change of office diastolic blood pressure
Time frame: 6 month
change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability
Time frame: 6 month
Change in plasma norepinephrine
Time frame: 6 months
Change in pulse wave velocity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 23453868Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Bohm M, Lambert EA, Krum H, Sobotka PA, Schmieder RE, Ika-Sari C, Eikelis N, Straznicky N, Lambert GW, Esler MD. Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with end-stage renal disease. Int J Cardiol. 2013 Oct 3;168(3):2214-20. doi: 10.1016/j.ijcard.2013.01.218. Epub 2013 Feb 28.
- Background: PubMed 23248063Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880.
- Background: PubMed 21403086Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
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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.
Kiyuk Chang, MD, PhD principal investigator
Seoul St. Mary's Hospital
Sung Ho Her, MD, PhD principal investigator
Daejon St. Mary's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal sympathetic denervation in people with Hypertension, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiyuk Chang, MD, PhD (+822-2258-1139, kiyuk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of office systolic blood pressure after renal denervation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346045, which also lists 3 linked publications.
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 26 Jan 2015.