Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Proportion of participants with complete biochemical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy.
研究概览
简要总结
The goal of this project is to improve the diagnostic pathway for patients with primary aldosteronism, by validating non-invasive biomarkers coupled with routine computed tomography imaging. The aim is to reduce reliance on invasive procedures, shorten diagnostic timelines, and enhance accessibility to definitive diagnosis and treatment globally.
详细描述
Primary Aldosteronism is a common but under-diagnosed condition, despite being a curable cause of secondary hypertension with significant long-term health consequences if left untreated. Once the diagnosis of primary aldosteronism is confirmed, subtype tests are required to demonstrate unilateral primary aldosteronism before curative surgery. Most patients need to undergo adrenal vein sampling, an invasive procedure performed under radiological guidance. However, this procedure is technically-challenging, with failure to cannulate both adrenal veins frequently leading to inconclusive results. Many patients worldwide may be offered surgery based on computed tomography imaging alone because of a lack of adrenal vein sampling expertise or a failed adrenal vein sampling result.
High hybrid hormones indicate a functional KCNJ5-mutant aldosterone-producing adenoma and, when coupled with computed tomography imaging, may provide a non-invasive alternative to adrenal vein sampling for identifying unilateral primary aldosteronism.
Ultimately, this trial aims to reduce the number of patients that will require an invasive adrenal vein sampling in future clinical diagnostics. This will improve access, and allow more patients to receive timely and curative treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary aldosteronism according to the Endocrine Society guideline
- •Willing to undergo subtype testing with adrenal vein sampling and/or molecular imaging (Positron Emission Tomography/Computed Tomography, PET/CT).
- •Keen for surgical treatment if shown to have unilateral primary aldosteronism.
排除标准
- •Inability to provide written informed consent.
研究组 & 干预措施
Hybrid hormones
Previous studies have shown that hybrid hormones are elevated in patients with unilateral primary aldosteronism who have large, visible adenomas in their adrenal glands. These tumors harbour a somatic KCNJ5 mutation and are also most likely to be cured of hypertension after surgery.
Hence, the investigators hypothesize that high hybrid hormones levels, in the presence of an adenoma on a computed tomography imaging would identify study participants who can proceed to surgery.
干预措施: Hybrid hormones (Diagnostic Test)
结局指标
主要结局
Proportion of participants with complete biochemical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy.
时间窗: 6 months
Proportion of participants with correction of hypokalaemia and normalisation of aldosterone-renin-ratio following unilateral adrenalectomy, as per PASO criteria.
Proportion of participants with KCNJ5-mutant aldosterone producing adenoma/nodule
时间窗: 6 months
Proportion of participants with histopathology and genetic confirmation of KCNJ5-mutant aldosterone producing adenoma/nodule in resected adrenals.
次要结局
- Proportion of participants with complete clinical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy.(6 months)
- Cost-effectiveness of using hybrid hormones coupled with computed tomography imaging versus other subtyping tests including adrenal vein sampling and/or molecular imaging in diagnosing participants with unilateral primary aldosteronism(6 months)
- Diagnostic criteria using hybrid hormones/ steroid profiling coupled with computed tomography imaging(6 months)