The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
研究概览
简要总结
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
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
- •18-70 years;
- •diagnosed as PA by SIT;
- •no lateralization of aldosterone secretion during AVS;
- •serum potassium ≥ 2.8 mmol/L after the stage I.
排除标准
- •Impaired renal function (Ccr<60 ml/min);
- •Impaired liver function (ALT, AST > 2.5 times upper limit of normal);
- •Patients with heart failure (NYHA≥ class 3 or EF < 50%);
- •Patients with stroke or acute infarction in the last 6 months;
- •Patients who are pregnant or breastfeeding;
- •Patients who cannot tolerate dietary arrangements;
- •Patients with history of malignant tumors in the last 6 months.
结局指标
主要结局
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
时间窗: 2 weeks
次要结局
- The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.(2 weeks)
研究者
Wang Weiqing
Director,head of Endocrinololgy,Principal Investigator,Clinical Professor
Shanghai Jiao Tong University School of Medicine