IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Mean home systolic blood pressure
研究概览
简要总结
Purpose of this clinical trial is to improve prediction of outcomes from surgical intervention in patients with Primary aldosteronism, and evaluate the merits of non-invasive metomidate PET CT versus adrenal vein sampling in the diagnosis of surgically correctable aldosteronism.
详细描述
This is an observational multi-centre prospective cohort study which takes place within secondary and tertiary care. All participants will have the same two investigations performed in random order. These are as follows:
11C- metomidate PET CT This is a one-hour non-invasive study, prior to which participants are treated with dexamethasone for 3 days. A proportion of patients will have an additional 18F-CETO PET CT scan to measure concordance between the two PET CT scans.
Adrenal Vein Sampling This is an invasive investigation in which both adrenal veins are cannulated and blood collected for measurement of adrenal steroid hormones. Adrenocorticotrophic hormone (ACTH) is administered prior to AVS in order to ensure steroid hormone secretion during the procedure.
The investigators will standardise the start-time of treatment with spironolactone, which is first-choice treatment for participants with primary aldosteronism, in order that the pre-spironolactone blood pressure and biochemistry can be compared with subsequent measurements post-surgery, and the changes during the first month of spironolactone treatment can be used to assess their value in predicting response to surgery.
Sub-study of Repeat 11-C Metomidate PET CT before and after Spironolactone therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean home systolic blood pressure
时间窗: Baseline to 6 month primary endpoint
Changes in average home systolic blood pressures
Normalisation of aldosterone renin ratio (ARR)
时间窗: Baseline to 6 month Primary endpoint
change in aldosterone- renin ratio for renin activity/renin mass
次要结局
- Change in quality of life(Baseline to 6 month Primary endpoint)
- change in troponin, Brain naturetic pepetide(Baseline to 6 month Primary endpoint)
- change in cardiac MRI measurements(Baseline to 6 month Primary endpoint)
- Change in Aldosterone - renin ratio renin activity/renin mass (ARR)(Baseline to 6 month Primary endpoint)
- Biochemical success using PASO categorical criteria complete, partial or absent(Baseline to 6 month Primary endpoint)
- Change in home systolic and diastolic blood pressure(Baseline to 6 month Primary endpoint)
- Clinical success using PASO categorical criteria complete, partial or absent(Baseline to 6 month Primary endpoint)
- Normal range serum potassium levels(Baseline to 6 month Primary endpoint)
- Change in clinic systolic and diastolic blood pressures(Baseline to 6 month Primary endpoint)