title: Effect of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN33941607.
authors.affiliation: Department of Cardiology, Medical University of Graz, Auenbruggerplatz 15, Graz, 8036, Austria. andreas.tomaschitz@gmx.at.
authors.forename: Andreas
authors.initials: A
authors.lastname: Tomaschitz
authors.forename: Astrid
authors.initials: A
authors.lastname: Fahrleitner-Pammer
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.forename: Nicolas
authors.initials: N
authors.lastname: Verheyen
authors.forename: Karin
authors.initials: K
authors.lastname: Amrein
authors.forename: Eberhard
authors.initials: E
authors.lastname: Ritz
authors.forename: Katharina
authors.initials: K
authors.lastname: Kienreich
authors.forename: Jörg H
authors.initials: JH
authors.lastname: Horina
authors.forename: Albrecht
authors.initials: A
authors.lastname: Schmidt
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kraigher-Krainer
authors.forename: Caterina
authors.initials: C
authors.lastname: Colantonio
authors.forename: Andreas
authors.initials: A
authors.lastname: Meinitzer
authors.forename: Stefan
authors.initials: S
authors.lastname: Pilz