Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism: A Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- The proportion of complete biochemical remission
研究概览
简要总结
This study is a prospective, multicenter, randomized clinical trial aimed to compare the impact of three AVS diagnostic strategies on the clinical outcomes of patients with primary aldosteronism. The strategies include sequential combined AVS (non-ACTH-stimulated followed by ACTH-stimulated AVS), non- ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. The findings of this study will provide critical evidence for the clinical practice standards of AVS.
详细描述
This is a prospective, multicenter, randomized controlled clinical trial. This study will be led by the First Affiliated Hospital of Chongqing Medical University, with Chuxiong Yi Autonomous Prefecture People's Hospital, the First Affiliated Hospital of Kunming Medical University, and the First Affiliated Hospital of Nanchang Medical University serving as collaborating centers. According to the inclusion and exclusion criteria, eligible patients with confirmed primary aldosteronism (PA) will be enrolled and randomly assigned in a 1:1:1 ratio to one of the following groups: sequential combined AVS, non-ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. These stratifications will guide clinical treatment decisions, either surgical therapy or medical therapy, and patients will be followed to evaluate their clinical outcomes. The primary outcome is the treatment response rate at 6-month follow-up, which will be compared among the three groups.
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
- 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
- •Fully understand the study process, voluntarily agree to participate, and sign informed consent.
- •Diagnosed with primary aldosteronism. # Age 18-70 years with hypertension, any sex.
排除标准
- •Patients for whom AVS can be bypassed: Typical BPA (normal serum potassium and plasma aldosterone concentration (PAC) < 110 pg/mL, eligible for direct medical therapy); Typical UPA (PAC ≥ 200 pg/mL, plasma renin concentration (PRC) ≤ 5 μIU/mL, spontaneous hypokalemia, unilateral adrenal adenoma ≥ 1 cm with normal contralateral adrenal on CT or 68Ga-Pentixafor PET-CT indicating unilateral functional tumor, eligible for direct surgery);
- •Refusal of AVS or surgery, or contraindication to surgery.
- •Allergy to ACTH or contrast agents.
- •Combined with autonomous cortisol secretion (1 mg overnight dexamethasone suppression test cortisol ≥ 50 nmol/L).
- •Early-onset hypertension (<20 years) with hypokalemia and family history, suggestive of familial hyperaldosteronism or Liddle syndrome.
- •Imaging cannot exclude pheochromocytoma or adrenocortical carcinoma (nodule ≥ 4 cm, CT ≥ 20 HU, or MRI suggestive).
- •Active malignancy.
- •Previous adrenal surgery.
- •Chronic glucocorticoid use that cannot be discontinued.
- •Adrenal insufficiency requiring hormone replacement.
- •Pregnancy or breastfeeding; history of alcohol or substance abuse, or inability to cooperate due to psychiatric disorders.
- •NYHA class III-IV heart failure or hospitalization for worsening heart failure in the past 3 months, stroke or acute coronary syndrome in past 3 months, severe anemia (Hb < 60 g/L), severe liver or renal disease (ALT ≥ 3×upper limit; eGFR <30 mL/min/1.73 m2 or dialysis), systemic inflammatory response syndrome (SIRS), poorly controlled diabetes (FBG ≥ 13.3 mmol/L), severe obesity (BMI ≥ 35 kg/m2), untreated aneurysm, or other conditions severely interfering with study participation.
结局指标
主要结局
The proportion of complete biochemical remission
时间窗: At 6 months of follow-up
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
- The proportion of complete clinical response rate(At 6 months of follow-up)
- In surgical population, the proportion of complete clinical remission(At 6 months of follow-up)
- In medication population, the proportion of complete clinical response rate(At 6 months of follow-up)
- In medication population, the proportion of complete biochemical response rate(At 6 months of follow-up)
- Comparison of adverse events(At 6 months of follow-up)
- In surgical population, the proportion of complete biochemical remission(At 6 months of follow-up)
- The proportion of complete clinical remission(At 6 months of follow-up)
- The proportion of complete biochemical response rate(At 6 months of follow-up)
研究者
Shumin Yang
Primary investigator
Chongqing Medical University