Adrenal Venous Sampling Under 1 mg Overnight Dexamethasone Suppression Test to Determine Subtype in Primary Aldosteronism，a Single Center, Randomized, Double Blended, Placebo Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Complete biochemical remission
研究概览
简要总结
To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA
详细描述
All paticipants will be randomly divided into 1mg DST group(Intervention group,n=43) and placebo group(Control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with PA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above, male or female, with legal capacity;
- •Patients who diagnosed as primary aldosteronism and willing to surgery
排除标准
- •Pregnant or lactating women
- •Patients with a history of malignant tumors or complicated with severe heart disease, eGFR<30ml/min/1.73m2, severe anemia (Hb<60g/L), stroke or acute coronary syndrome within 3 months, severe liver disease
- •Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
- •PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;
研究组 & 干预措施
AVS after 1mg DST
Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS
干预措施: Dexamethasone 1 MG Oral Tablet (Drug)
AVS after placebo
Patients divided into AVS after placebo group need to oral placebo the night before AVS
干预措施: Placebo (Drug)
结局指标
主要结局
Complete biochemical remission
时间窗: 1year
Compare the rate of complete biochemical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
Complete clinical remission
时间窗: 1 year
Compare the rate of complete clinical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
次要结局
- Successful catheterization rate(procedure)
- Daily defined doses of antihypertensive agents(1 year)
- Adverse events(3 month)