Department of Cardiology, Medical University of Graz, Auenbruggerplatz 15, Graz, 8036, Austria.
BMC Endocr Disord. 2012 Sep 13;12:19. doi: 10.1186/1472-6823-12-19.
Increasing evidence suggests the bidirectional interplay between parathyroid hormone and aldosterone as an important mechanism behind the increased risk of cardiovascular damage and bone disease observed in primary hyperparathyroidism. Our primary object is to assess the efficacy of the mineralocorticoid receptor-blocker eplerenone to reduce parathyroid hormone secretion in patients with parathyroid hormone excess.
METHODS/DESIGN: Overall, 110 adult male and female patients with primary hyperparathyroidism will be randomly assigned to eplerenone (25 mg once daily for 4 weeks and 4 weeks with 50 mg once daily after dose titration] or placebo, over eight weeks. Each participant will undergo detailed clinical assessment, including anthropometric evaluation, 24-h ambulatory arterial blood pressure monitoring, echocardiography, kidney function and detailed laboratory determination of biomarkers of bone metabolism and cardiovascular disease.The study comprises the following exploratory endpoints: mean change from baseline to week eight in (1) parathyroid hormone(1-84) as the primary endpoint and (2) 24-h systolic and diastolic ambulatory blood pressure levels, NT-pro-BNP, biomarkers of bone metabolism, 24-h urinary protein/albumin excretion and echocardiographic parameters reflecting systolic and diastolic function as well as cardiac dimensions, as secondary endpoints.
In view of the reciprocal interaction between aldosterone and parathyroid hormone and the potentially ensuing target organ damage, the EPATH trial is designed to determine whether eplerenone, compared to placebo, will effectively impact on parathyroid hormone secretion and improve cardiovascular, renal and bone health in patients with primary hyperparathyroidism.
ISRCTN33941607.
越来越多的证据表明，甲状旁腺激素和醛固酮之间的双向相互作用是原发性甲状旁腺功能亢进症患者心血管损伤和骨病风险增加的重要机制。我们的主要目的是评估盐皮质激素受体阻滞剂螺内酯降低甲状旁腺激素分泌过多患者甲状旁腺激素的疗效。
方法/设计：总共将 110 名成年男性和女性原发性甲状旁腺功能亢进症患者随机分为螺内酯组（25mg 每日一次，持续 4 周，然后根据剂量滴定，每周 50mg 一次，持续 4 周）或安慰剂组，共 8 周。每位参与者将接受详细的临床评估，包括人体测量评估、24 小时动态动脉血压监测、超声心动图、肾功能和骨代谢及心血管疾病生物标志物的详细实验室测定。该研究包括以下探索性终点：（1）从基线到第 8 周的甲状旁腺激素（1-84）的平均变化，作为主要终点；（2）24 小时收缩压和舒张压、NT-pro-BNP、骨代谢生物标志物、24 小时尿蛋白/白蛋白排泄和反映收缩和舒张功能以及心脏尺寸的超声心动图参数的变化，作为次要终点。
鉴于醛固酮和甲状旁腺激素之间的相互作用以及潜在的靶器官损伤，EPATH 试验旨在确定与安慰剂相比，螺内酯是否能有效影响甲状旁腺激素的分泌，并改善原发性甲状旁腺功能亢进症患者的心血管、肾脏和骨骼健康。
ISRCTN33941607。
