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

NCT02346045 | Unknown Phase 3 DMC

• 2 other identifiers: XC13EIMV0110DRDN-ESRD-CMC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

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

Conditions

Hypertension

Keywords

hypertension

Outcome Measures

Primary Outcomes (1)

• The change of office systolic blood pressure after renal denervation

  6 month

Secondary Outcomes (4)

• Change of office diastolic blood pressure

  6 month

• change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability

  6 month

• Change in plasma norepinephrine

  6 months

• Change in pulse wave velocity

  6 months

Study Arms (2)

Renal sympathetic denervation

EXPERIMENTAL

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

Procedure: Renal sympathetic denervation

Medical therapy

SHAM COMPARATOR

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

Procedure: Renal sympathetic denervation

Interventions

Renal sympathetic denervation PROCEDURE

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

Also known as: Catheter based based renal sympathetic denervation, Symplicity catheter system by Medtronic

Medical therapy; Renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (4)

Daejon St. Mary's Hospital

Daejeon, Chungchung Nam Do, 301-723, South Korea

RECRUITING

Chungnam National University

Daejeon, Chungchungnamdo, 301-721, South Korea

RECRUITING

Pohang St. Mary's Hospital

Pohang, Kyungsangnamdo, 790-825, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 23453868 BACKGROUND

• 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.

  PMID: 23248063 BACKGROUND

• 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.

  PMID: 21403086 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kiyuk Chang, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sung Ho Her, MD, PhD

  Daejon St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiyuk Chang, MD, PhD

CONTACT

+822-2258-1139; kiyuk@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, chief of division of cardiology

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: January 26, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2018
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

KR (4)