Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
Majority of patients with hypertension have primary hypertension (without an underlying cause). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally.
PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication.
It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results.
Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease)
排除标准
- •i. Unable to give consent ii. < 21 years or > 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding
研究组 & 干预措施
Medical Treatment
Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests)
干预措施: Mineralocorticoid Receptor Antagonists (Drug)
Surgical Treatment
Patients with unilateral PA who underwent adrenalectomy
干预措施: Adrenalectomy (Procedure)
结局指标
主要结局
Blood Pressure
时间窗: Change from Baseline Blood Pressure at 12 months
Blood pressure assessed by 24hr ambulatory BP
次要结局
- Cure of Primary aldosteronism(Change from Baseline Status of primary aldosteronism at 12 months)
- Quality of Life (RAND-36)(Change from Baseline Quality of Life RAND-36 at 12 months)
- Quality of Life ( Beck's depression inventory II)(Change from Baseline Quality of Life (BDI-II) at 12 months)
- Quality of Life (EQ5D)(Change from Baseline EQ5D at 12 months)
- Fasting glucose(Change from Baseline Fasting glucose at 12 months)
- Renal Function(Change from Baseline Renal Function at 12 months)
- weight(Change from Baseline weight at 12 months)
- Blood Pressure(Change from Baseline Clinic Blood Pressure at 12 months)
- Cardiac function(Change from Baseline Cardiac function at 12 months.)
- Left ventricular hypertrophy(Change from Baseline Left ventricular hypertrophy at 12 months)
- Control of hypertension(Change from Baseline Status of hypertension control at 12 months)
- Use of antihypertension medications(Change from Baseline Antihypertension medications at 12 months)
- Lipids(Change from Baseline Lipids at 12 months)
- Transaminitis(Change from Baseline transaminitis at 12 months)
- Insulin Resistance(Change from Baseline Insulin resistance at 12 months)