Clinical trial NCT02346045: Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension
Official title: Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
name: Daiichi Sankyo Korea Co., Ltd.
First posted: 2015-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The change of office systolic blood pressure after renal denervation
timeFrame: 6 month
Secondary outcomes:
measure: Change of office diastolic blood pressure
timeFrame: 6 month
measure: change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability
timeFrame: 6 month
measure: Change in plasma norepinephrine
timeFrame: 6 months
measure: Change in pulse wave velocity
timeFrame: 6 months
Other outcomes:
Locations:
city: Daejon
country: Korea, Republic of
facility: Daejon St. Mary's Hospital
state: Chungchung nam do
city: Daejon
country: Korea, Republic of
facility: Chungnam National University
state: Chungchungnamdo
city: Pohang
country: Korea, Republic of
facility: Pohang St. Mary's Hospital
state: Kyungsangnamdo
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kiyuk Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daejon St. Mary's Hospital
name: Sung Ho Her, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.