Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Cure of Primary Aldosteronism Post-Adrenalectomy
研究概览
简要总结
10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.
Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.
详细描述
25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.
Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone >140pmol/L); or hypokalemia with undetectable renin levels and aldosterone >550pmol/L.
排除标准
- •Inability to provide written informed consent
- •< 21 years or > 70 years
- •Chronic renal failure of Stage 3b or greater severity
- •Severe or terminal medical condition(s)
- •Contraindications to isotope scanning or CT Scan
- •Contraindication to ingestion of corticosteroids
结局指标
主要结局
Cure of Primary Aldosteronism Post-Adrenalectomy
时间窗: 6 months
Percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using AVS
次要结局
- Clinical Diagnosis of Unilateral Primary Aldosteronism(6 months)
- Cost-Effectiveness of Diagnostic Test(6 months)