Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension, End-stage Chronic Kidney Disease and Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety endpoints and adverse effects
研究概览
简要总结
The RDN-HD Study is a prospective, single-center feasibility study. All patients included will undergo endovascular ultrasound-based RDN (no sham group, no blinding). The purpose of the RDN-HD Study is to demonstrate that ultrasound-based RDN is safe in patients with TRH and ESRD hemodialysis and reduces 24-h ambulatory BP.
详细描述
Patients with end-stage renal disease (ESRD) and hemodialysis have a very high risk for cardiovascular events and a very high cardiovascular mortality. Uncontrolled treatment resistant hypertension (TRH) is an important factor driving this very high cardiovascular event risk. Clinical and experimental studies have clearly shown that sympathetic nerve activity is increased in patients with chronic kidney disease (CKD) and substantially aggravates the progression of CKD. In patients with ESRD and chronic hemodialysis bilateral nephrectomy reduced increased sympathetic nerve activity. Interestingly, kidney transplantation did not normalize peripheral sympathetic activity unless the native kidneys were removed. Thus, afferent sensory nerve signaling from the diseased kidneys to the central nervous system is an important pathophysiologic mechanism in CKD leading to sympathetic overactivity and hypertension. Clinical studies have demonstrated that invasive, catheter-based renal denervation (RDN) decreases the sympathetic nerve activity in the whole body and in particular in the kidneys
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncontrolled treatment resistant hypertension (despite intake of 3 different classes of antihypertensive medications) confirmed by 24-h ambulatory blood pressure according to current guidelines (ESH 2023) (office blood pressure ≥ 140/ and/ or ≥ 90 mmHg and ambulatory blood pressure ≥ 130/ and/or ≥ 80 mmHg
- •end-stage renal disease on chronic hemodialysis
- •Stable hemodialysis regime for at least 3 months based on the decision of the treating physician
- •Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks.
- •Individual is ≥ 18 years of age, male and female patients are included.
排除标准
- •Episodes of sustained systolic and/or diastolic hypotension according to 24-h ambulatory blood pressure or dialysis protocols which in the eyes of the treating physician would interfere with a safe renal denervation treatment of the patient
- •Known hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
- •Prior renal denervation procedure
- •Anatomic or functional solitary kidney, kidney transplantation
- •Severe atherosclerotic disease or artery calcification preventing the assessment of reliable BP measurements
- •Endocrine hypertension other than obstructive sleep apnea
- •Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
- •Acute episode of systemic and renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months
- •Subject is pregnant, nursing, or intends to become pregnant
- •Enrollment in another interventional research protocol.
- •Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)
结局指标
主要结局
Safety endpoints and adverse effects
时间窗: during 6 months post-procedure
A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure
时间窗: baseline and 3 months post-procedure
次要结局
- Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)
- Number of antihypertensive drugs, doses, classes at 3, 6 months post-procedure compared to baseline.(at 3, 6 months post-procedure compared to baseline.)
- Change in central systolic and diastolic blood pressure, central pulse pressure and pulse wave velocity between baseline and 3,6 months post procedure(between baseline and 3,6 months post procedure)
- Change in retinal arteriolar wall to lumen ratio between baseline and 3,6 months post procedure(between baseline and 3,6 months post procedure)
- Change in average daytime/night-time ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)
- Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)
- Change in retinal capillary density between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)
- Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure(between baseline and 6 months post-procedure.)
- Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure.(between baseline and 3, 6 months post-procedure)
- Change in office (attended) and ambulatory heart rate between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)
- Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure(baseline and 3, 6 months post-procedure.)
- Change in bio-impedance parameters between baseline and 3, 6 months post-procedure to assess the volume status.(between baseline and 3, 6 months post-procedure)
- Change in average daytime/night-time ambulatory systolic blood pressure between baseline and 3, 6 months post-procedure.(between baseline and 3, 6 months post-procedure.)
- Change in retinal arterial remodeling between baseline and 3, 6 months post-procedure(between baseline and 3, 6 months post-procedure)