Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- The change of office systolic blood pressure after renal denervation
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Medical therapy
renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed)
干预措施: Renal sympathetic denervation (Procedure)
Renal sympathetic denervation
Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed)
干预措施: Renal sympathetic denervation (Procedure)
结局指标
主要结局
The change of office systolic blood pressure after renal denervation
时间窗: 6 month
次要结局
- 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 pulse wave velocity(6 months)
- Change in plasma norepinephrine(6 months)
- Change of office diastolic blood pressure(6 month)
研究者
Kiyuk Chang
Professor, chief of division of cardiology
Seoul St. Mary's Hospital