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

January 19, 2015 updated by: Kiyuk Chang, Seoul St. Mary's Hospital

Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea

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. Resistant hypertension is associated to sympathetic hyperactivity
  2. Renal sympathetic nerve is known to be associated with systemic sympathetic activity
  3. 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Seoul ST. Mary's Hospital
        • Contact:
        • Sub-Investigator:
          • Yoon- Seok Koh
    • Chungchung nam do
      • Daejon, Chungchung nam do, Korea, Republic of, 301-723
        • Recruiting
        • Daejon St. Mary's Hospital
        • Contact:
        • Sub-Investigator:
          • Chan Joon Kim, MD
    • Chungchungnamdo
      • Daejon, Chungchungnamdo, Korea, Republic of, 301-721
        • Recruiting
        • Chungnam National University
        • Contact:
          • Jin Ok Jung
    • Kyungsangnamdo
      • Pohang, Kyungsangnamdo, Korea, Republic of, 790-825
        • Recruiting
        • Pohang St. Mary's Hospital
        • Contact:
          • Seung Jae Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal sympathetic denervation
Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed)
Procedure: Renal sympathetic denervation

In 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

Other Names:
  • Catheter based based renal sympathetic denervation
  • Symplicity catheter system by Medtronic
Sham Comparator: Medical therapy
renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed)
Procedure: Renal sympathetic denervation

In 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

Other Names:
  • Catheter based based renal sympathetic denervation
  • Symplicity catheter system by Medtronic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of office systolic blood pressure after renal denervation
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of office diastolic blood pressure
Time Frame: 6 month
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
6 month
Change in plasma norepinephrine
Time Frame: 6 months
6 months
Change in pulse wave velocity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Sung Ho Her, MD, PhD, Daejon St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC13EIMV0110D
  • RDN-ESRD-CMC-01 (Other Grant/Funding Number: Daewoong, Daichi-Sankyo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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