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临床试验/NL-OMON45212
NL-OMON45212已完成不适用

Effects of aldosterone antagonism on microvascular function in obese individuals - Aldosterone antagonism and microvascular function

niversiteit Maastricht0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Age 40-65 years
  • - Caucasian (because of ethnic differences in microvascular function, vascular stiffness, and the prevalence of cardiovascular disease and associated risk factors)
  • - Waist circumference > 102 cm (men)/> 88 cm (women)
  • - High-normal blood pressure (office blood pressure: 130/85 * 139/89 mm Hg) or stage I/II hypertension (office blood pressure: 140/90 mm Hg * 179/109 mm Hg; 24h ABPM: 125/80 * 169/99 mm Hg)

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/impaired fasting glucose (fasting glucose values > 6.1 mmol/L), because not only diabetes, but also intermediate hyperglycaemia has been associated with microvascular disease, which impedes the distinction between cause and consequence of disturbances in glucose metabolism in the concerning individuals
  • - Grade 3 hypertension (office blood pressure: > 180/110 mm Hg; ABPM > 170/100 mm Hg) in order not to expose these individuals to unnecessary risks by interrupting or postponing antihypertensive treatment
  • - Unstable or severe pulmonary disease
  • - Unstable or severe thyroid disorders
  • - Inflammatory diseases
  • - Alcohol use > 2 U/day (women)/> 3 U/day (men)
  • - Use of glucose-lowering medications, because of possible interference with microvascular function
  • - Use of corticosteroids (have also affinity for the mineralocorticoid receptor; can decrease the antihypertensive effect of Eplerenone), medication known to inhibit or induce CYP3A4 (possible interference with metabolism of Eplerenone), lithium (possible reduction of lithium excretion when used simultaneously with Eplerenone) , and tricyclic antidepressants or antipsychotic medication (risk of orthostatic hypotension when used simultaneously with Eplerenone), and regular use (weekly or several times a week) of NSAIDs (risk of acute renal dysfunction and disturbance of electrolyte excretion when used simultaneously with Eplerenone)
  • - Plasma potassium levels < 3.2 mmol/L or > 5 mmol/L
  • - eGFR < 60 mL/min
  • - Impairment of hepatic function
  • - Pregnancy or lactation

研究者

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