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

Study Overview
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Brief Summary
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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

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

Conditions
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Hypertension

Intervention / Treatment
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* Procedure: Renal sympathetic denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal sympathetic denervation<br>Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed) | Procedure: Renal sympathetic denervation<br>* 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<br>* Other names: Symplicity catheter system by Medtronic;|
| Sham Comparator: Medical therapy<br>renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed) | Procedure: Renal sympathetic denervation<br>* 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<br>* Other names: Symplicity catheter system by Medtronic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension