Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
研究概览
简要总结
Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. This study intends to conduct renal sympathetic denervation ablation from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.
详细描述
Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone.
This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Renal artery diameter ≥4 mm and Length ≥20 mm;
- •. 18 years old ≤ age ≤ 70 years old;
- •. Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study;
- •. Clinic systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥95 mmHg) .
- •. 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;
- •. Estimated GFR (eGFR)≥45 ml/min / 1.73 m2.
排除标准
- •. Renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); Underwent renal artery balloon angioplasty or inserting a stent; Renal artery anatomy apparently is unusual to insert catheter;
- •. Cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; Thrombus or unstable plaques in the arteries with extensive atherosclerosis; Hemodynamic apparently change in patients with heart valve disease;
- •. The patients with typeⅠdiabetes;
- •. Other serious organic disease;
- •. Participated in other clinical research.
结局指标
主要结局
Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
时间窗: at 6 months,12 months,18 months
The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months
次要结局
- Change from Baseline Renin at 6 months,12 months, 18 months(at 6 months,12 months,18 months)
- Change from Baseline aldosterone at 6 months,12 months, 18 months(at 6 months,12 months,18 months)
研究者
Chuanyu Gao
Principal Investigator
Henan Institute of Cardiovascular Epidemiology