The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Association of any renal cyst finding to graded baseline renin concentration (mU/L)
研究概览
简要总结
During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Adrenal computed tomographies are analysed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.
详细描述
Aim of the study is to evaluate the prevalence of renal cysts and their association with renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.
In a prospective study up to 200 patients who have been referred to Tampere University Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical, medication, radiological and laboratory information according to Endcrine Society guidelines is collected. Interventional radiologist will draw venous blood from both renal veins and from IVC for later renin analyses. One, blinded radiologist will record renal pathology of cysts but also other abnormal radiologic features.
An interim analysis will be done when 60-100 patients have been recruited or at 6-12 months from the start of the study. Study will be stopped if significant difference can be found in renin measurement in patients with renal cysts compared with patients without renal cysts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed primary aldosteronism according to Endocrine Society guidelines
- •Adrenal vein sampling performed in Tampere University Hospital
- •Informed consent
排除标准
- 未提供
结局指标
主要结局
Association of any renal cyst finding to graded baseline renin concentration (mU/L)
时间窗: Baseline
Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high
次要结局
- Correlation of renin activity (ng of Ang I/ml/h) in right and left renal vein from the side with or without renal cysts (or other renal pathology)(During procedure)
- Correlation of renin concentration (mU/L) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)(During procedure)
- Correlation of renin activity (ng of Ang I/ml/h) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)(During procedure)
- Association of prevalence of renal cysts (%) with severity of hypertension(Baseline)
- Association of prevalence of renal cysts (%) with duration (years) of hypertension(Baseline)
- Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts(During procedure)
- Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts(During procedure)
- Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)(Baseline)
- Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts(During procedure)
- Prevalence (%) of renal cysts in patients in computed tomography with contrast media(Baseline)
- Association of prevalence of renal cysts (%) with severity of primary aldosteronism(Baseline)
- Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups(Baseline)
- Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)(During procedure)
- Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney(During procedure)