Microvascular Function in Patients With Primary Aldosteronism and Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Microvascular recruitment in skeletal muscle during hyperinsulinaemia
研究概览
简要总结
Patients with primary aldosteronism, which is the most prevalent form of secondary hypertension, have an increased rate of cardiovascular events, compared to patients with essential hypertension, even with equal severity of hypertension. This might be partially attributed to the association of increased aldosterone levels with insulin resistance. How this relation can be explained from a pathophysiological point of view, is insufficiently established.
Recently, microvascular dysfunction has been proposed as a link between insulin resistance and hypertension. Loss of NO-mediated vasodilation is an important feature of microvascular dysfunction; in addition, an impaired insulin-mediated microvascular NO production has been suggested to underlie the reduction in insulin-stimulated glucose disposal that is characteristic of insulin-resistant states. Increased aldosterone levels are not only associated with insulin resistance, but also with endothelial dysfunction. In addition, they interfere with the vascular effects of insulin.
Therefore, the investigators hypothesize that in patients with primary aldosteronism, increased aldosterone levels induce microvascular dysfunction through reduction of NO-availability, which contributes to the development of insulin resistance, and of hypertension, in addition to the sodium-retaining effects of aldosterone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary aldosteronism
- •Age 18-70 years
- •Confirmed diagnosis of primary aldosteronism
- •Serum potassium > 3.5 mmol/L with or without supplementation
- •Patients with essential hypertension
- •Age 18-70 years
- •Secondary causes of hypertension excluded
排除标准
- •Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- •Diabetes mellitus
- •Unstable or severe pulmonary disease
- •Inflammatory diseases
- •Alcohol use > 2 U/day (women) / > 3 U/day (men)
- •(Frequent) use of acetylsalicylic acid, NSAID's, dipyridamole and corticosteroids
- •eGFR < 60 mL/min
- •Impairment of hepatic function
- •Pregnancy or lactation
研究组 & 干预措施
Primary aldosteronism
Patients with primary aldosteronism, who undergo surgery or will be started on antihypertensive medication, including mineralocorticoid receptor antagonists
干预措施: Adrenal extirpation (Procedure)
Primary aldosteronism
Patients with primary aldosteronism, who undergo surgery or will be started on antihypertensive medication, including mineralocorticoid receptor antagonists
干预措施: Antihypertensive medication (Drug)
Essential hypertension
Patients with essential hypertension who will be started on antihypertensive medication
干预措施: Antihypertensive medication (Drug)
结局指标
主要结局
Microvascular recruitment in skeletal muscle during hyperinsulinaemia
时间窗: 3 months after (initiation of) treatment
次要结局
未报告次要终点
研究者
Monica Schütten
MD
Maastricht University Medical Center