A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- changes in 24-hour urinary aldosterone levels
研究概览
简要总结
The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.
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
- None
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
- •Clinical diagnosis of primary aldosteronism
排除标准
- •Allergy to drugs in this study
- •Pregnancy
- •Severe liver and kidney dysfunction
- •Mental illness
研究组 & 干预措施
Simvastatin combined with Amlodipine besylate
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months
干预措施: Simvastatin combined with Amlodipine besylate (Drug)
Simvastatin combined with Spironolactone and Amlodipine besylate.
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months
干预措施: Simvastatin combined with Spironolactone and Amlodipine besylate. (Drug)
Amlodipine besylate combined with Spironolactone
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months
干预措施: Amlodipine besylate combined Spironolactone (Drug)
结局指标
主要结局
changes in 24-hour urinary aldosterone levels
时间窗: 6 month
24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h)
changes in plasma aldosterone levels
时间窗: 6 month
blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml)
次要结局
- changes in serum potassium levels(6 month)
- changes in office blood pressure and home blood pressure(6 month)
- changes in serum renin level(6 month)
- changes in plasma cholesterol levels(6 month)
- changes in blood glucose(6 month)
研究者
Zhiming Zhu
Department of Hypertension and Endocrinology
Third Military Medical University