Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Long-term clinical outcome after surgical and medical treatment of PA
研究概览
简要总结
In this study the investigators aim to identify and include consecutively patients with primary aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the characteristics of these patients, to explore the cardiac effects of PA before and after specific treatment, and to identify long-term outcomes after treatment. One subgroup of the PA patients perform echocardiography to assess left ventricular systolic myocardial function before and after treatment. One subgroup of PA patients perform cardiac MRI to assess myocardial mass, myocardial fibrosis and myocardial function in rest and during stress, before and after treatment. For the cardiac MRI substudy, the PA patients are compared with a group of healthy controls, also included in the study.
From 2022 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
详细描述
From June 2013, all newly diagnosed patients with primary aldosteronism (PA) either diagnosed at Haukeland University Hospital (HUS) or admitted to HUS for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. All included patients have a base-line study visit where clinical information is registered, and baseline blood and urine samples are collected. Echocardiography will be performed in a subgroup of patients before and 1 year after start of specific PA treatment. After start of definite medical or surgical treatment the patients are followed up with regularly new study visits. From 2025 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
A subgroup of the included PA study patients also perform a Cardiac MRI. Cine-MRI, velocity-encoded MRI, MRI images during continuous adenosine infusion and MRI images after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls.
From 2025 onwards, PA patients either diagnosed or performing subtyping with adrenal vein sampling at Oslo University Hospital will likewise be asked for study inclusion.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Verified diagnosis or strong suspicion of primary aldosteronism
- •Age 18-85
排除标准
- •Active cancer disease at time of inclusion
- •Exclusion criteria for subgroup of primary aldosteronism-patients and healthy controls who perform cardiac MRI:
- •Asthma/chronic obstructive pulmonary disease ,
- •Use of dipyridamole
- •Claustrophobia
结局指标
主要结局
Long-term clinical outcome after surgical and medical treatment of PA
时间窗: 5 years
Systolic and diastolic blood pressure (mm Hg) will be measured after specific PA treatment for estimation of clinical blood pressure outcome. In adrenalectomized patients clinical outcome will be determined following the international standardized Primary Aldosteronism Surgery Outcome (= PASO) criteria.
Long-term biochemical outcome after surgical treatment of PA
时间窗: 5 years
Biochemical outcome after unilateral adrenalectomy will be determined by measurement of aldosterone (pmol/L), direct renin-concentration (mIE/L) for estimation of aldosterone/renin-ratio and potassium (mmol/L) in blood, following the international standardized PASO (primary aldosteronism surgery outcome) criteria.
次要结局
- Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment(3 years)
- Echocardiographic assessment of left ventricular mass in PA patients before and after treatment(3 years)
- Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls(3 years)
- Cardiac MRI assessment of left coronary flow reserve(3 years)
- Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment(3 years)
- Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36)(5 years)
- Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment(3 years)