LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- 2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)
研究概览
简要总结
The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.
详细描述
Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
- •Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg
- •Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
- •eGFR ≥45 mL/min/1.73 m2
- •Written informed consent
排除标准
- •Clinical Exclusion Criteria:
- •Known secondary hypertension
- •Type 1 diabetes mellitus
- •Has an implantable cardioverter defibrillator (ICD) or pacemaker
- •Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- •Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
- •Has hemodynamically significant valvular heart disease
- •Pregnant, nursing, or planning to be pregnant
- •Any serious medical condition that may adversely affect the safety of the participant or the study
- •Currently enrolled in another investigational drug or device trial
- •Anatomic Exclusion Criteria
- •Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- •History of prior renal artery intervention including balloon angioplasty or stenting
- •Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- •Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
- •Renal artery abnormalities
结局指标
主要结局
2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)
时间窗: through 6 months
Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline
时间窗: 6 months after RDN
次要结局
- Reduction in 24-h ambulatory blood pressure(ABPM) parameters(1 month,3 months,6 months after RDN)
- Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission(1 month,3 months,6 months after RDN)
- Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）(Perioperative period)
- Change in office SBP and DBP at 1, 3 months(1 month, 3 months after RDN)
- Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months(1 month, 3 months after RDN)
- Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%(6 months after RDN)