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Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renal sympathetic denervation
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known secondary hypertension patients

  • Patients who have renal artery which is not adequate for renal denervation

    1. The main renal artery diameter < 4 mm, or renal artery length < 20 mm
    2. The renal arteries into which stable catheter insertion is difficulty and which have hemodynamically or anatomically significant stenosis
    3. 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
  • 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

Sites / Locations

  • Daejon St. Mary's HospitalRecruiting
  • Chungnam National UniversityRecruiting
  • Pohang St. Mary's HospitalRecruiting
  • Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal sympathetic denervation

Medical therapy

Arm Description

Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed)

renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed)

Outcomes

Primary Outcome Measures

The change of office systolic blood pressure after renal denervation

Secondary Outcome Measures

Change of office diastolic blood pressure
change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability
Change in plasma norepinephrine
Change in pulse wave velocity

Full Information

First Posted
October 21, 2013
Last Updated
January 19, 2015
Sponsor
Seoul St. Mary's Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD., Daiichi Sankyo Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02346045
Brief Title
Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension
Official Title
Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD., Daiichi Sankyo Korea Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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. D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic denervation is expected to improve resistant hypertension in ESRD patients F. The aim the present study is to evaluate the effects and safety of catheter based renal sympathetic denervation on resistant hypertension in ESRD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal sympathetic denervation
Arm Type
Experimental
Arm Description
Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed)
Arm Title
Medical therapy
Arm Type
Sham Comparator
Arm Description
renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed)
Intervention Type
Procedure
Intervention Name(s)
Renal sympathetic denervation
Other Intervention Name(s)
Catheter based based renal sympathetic denervation, Symplicity catheter system by Medtronic
Intervention Description
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
Primary Outcome Measure Information:
Title
The change of office systolic blood pressure after renal denervation
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Change of office diastolic blood pressure
Time Frame
6 month
Title
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
Title
Change in plasma norepinephrine
Time Frame
6 months
Title
Change in pulse wave velocity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyuk Chang, MD, PhD
Phone
+822-2258-1139
Email
kiyuk@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Ho Her, MD, PhD
Organizational Affiliation
Daejon St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daejon St. Mary's Hospital
City
Daejon
State/Province
Chungchung nam do
ZIP/Postal Code
301-723
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Ho Her, MD, PhD
Phone
+8242-220-9686
Email
hhhsungho@hanmail.net
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, MD
Facility Name
Chungnam National University
City
Daejon
State/Province
Chungchungnamdo
ZIP/Postal Code
301-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ok Jung
Facility Name
Pohang St. Mary's Hospital
City
Pohang
State/Province
Kyungsangnamdo
ZIP/Postal Code
790-825
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Jae Lee, MD
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang, MD, PhD
Phone
+822-2258-1139
Email
kiyuk@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yoon- Seok Koh

12. IPD Sharing Statement

Citations:
PubMed Identifier
23453868
Citation
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.
Results Reference
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PubMed Identifier
23248063
Citation
Esler 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.
Results Reference
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PubMed Identifier
21403086
Citation
Symplicity 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.
Results Reference
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Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension

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