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

Phase 3

• Conditions: Hypertension
• Interventions: Procedure: Renal sympathetic denervation

• Registration Number: NCT02346045
• Lead Sponsor: Seoul St. Mary's Hospital

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. 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-21
• Study Start: 2014-09
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-19
• Last Update Submitted: 2015-01-19
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26
• Primary Completion: 2015-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal sympathetic denervation	Renal sympathetic denervation	Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed)
Medical therapy	Renal sympathetic denervation	renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed)

Primary Outcome Measures

Name	Time	Method
The change of office systolic blood pressure after renal denervation	6 month

Secondary Outcome Measures

Name	Time	Method
Change in pulse wave velocity	6 months
Change in plasma norepinephrine	6 months
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 of office diastolic blood pressure	6 month

Trial Locations

Locations (4)

Daejon St. Mary's Hospital; 🇰🇷 Daejon, Chungchung nam do, Korea, Republic of

Chungnam National University; 🇰🇷 Daejon, Chungchungnamdo, Korea, Republic of

Pohang St. Mary's Hospital; 🇰🇷 Pohang, Kyungsangnamdo, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of