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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346045
• Other study ID #: XC13EIMV0110D
• Secondary ID: RDN-ESRD-CMC-01
• Status: Recruiting
• Phase: Phase 3
• First received: October 21, 2013
• Last updated: January 19, 2015
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: January 2015
• Source: Seoul St. Mary's Hospital
• Contact: Kiyuk Chang, MD, PhD
• Phone: +822-2258-1139
• Email: kiyuk[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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 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

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University	Daejon	Chungchungnamdo
Korea, Republic of	Daejon St. Mary's Hospital	Daejon	Chungchung nam do
Korea, Republic of	Pohang St. Mary's Hospital	Pohang	Kyungsangnamdo
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Daewoong Pharmaceutical Co. LTD., Daiichi Sankyo Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Esler MD, Krum H, Schlaich M, Schmieder RE, Böhm 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. — View Citation

Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Böhm 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of office systolic blood pressure after renal denervation		6 month	No
Secondary	Change of office diastolic blood pressure		6 month	No
Secondary	change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability		6 month	No
Secondary	Change in plasma norepinephrine		6 months	No
Secondary	Change in pulse wave velocity		6 months	No