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Open Access Study protocol

Effect of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial

Andreas Tomaschitz1*, Astrid Fahrleitner-Pammer2, Burkert Pieske1, Nicolas Verheyen1, Karin Amrein2, Eberhard Ritz3, Katharina Kienreich2, Jörg H Horina4, Albrecht Schmidt1, Elisabeth Kraigher-Krainer1, Caterina Colantonio1, Andreas Meinitzer5 and Stefan Pilz26*

Author Affiliations

1 Department of Cardiology, Medical University of Graz, Auenbruggerplatz 15, Graz, 8036, Austria

2 Department of Internal Medicine, Division of Endocrinology and Metabolism, Medical University of Graz, Auenbruggerplatz 15, Graz, 8036, Austria

3 Department of Medicine, Division of Nephrology, University Hospital Heidelberg, Heidelberg, Germany

4 Department of Internal Medicine, Division of Nephrology, Medical University of Graz, Graz, Austria

5 Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria

6 Department of Epidemiology and Biostatistics and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands

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BMC Endocrine Disorders 2012, 12:19  doi:10.1186/1472-6823-12-19

Published: 13 September 2012

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/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.

Discussion

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.

Trial registration

ISRCTN33941607

Keywords:
Aldosterone; Mineralocorticoid receptor blocker; Hyperparathyroidism