Primary hyperparathyroidism (PHPT) Nutritional, Metabolic, Endocrine Primary hyperparathyroidism
Conditions
Interventions
Overall, 110 participants will be randomized to 8 weeks of double-blind treatment with eplerenone 25mg and 50 mg once daily, respectively.
Eplerenone will be initiated at 25 mg once daily and titrat
Sponsors
Medical University of Graz (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Patients with PHPT: 2.1. Asymptomatic PHPT who do not meet guidelines for surgical treatment 2.2. Symptomatic PHPT in whom surgery is recommended, but not performed because of patient and/or physician preference or perceived medical contraindications 3. Age = 18 years
Exclusion criteria
Exclusion criteria: 1. 25 - hydroxy vitamin D [25(OH)D] levels 5.0 mEq/L (mmol/L) at baseline or > 5.5 mEq/L (mmol/L) during active study period 4. Pregnancy or lactating women 5. Drug intake as part of another clinical study 4 weeks before enrolment into the EPATH study and/or during the active study period 6. Any disease with an estimated life expectancy below 1 year 7. Chemotherapy or radiation therapy during the study 8. Intolerance to eplerenone or any ingredient occurring in eplerenone 9. Severe acute or chronic liver diseases (Child-Pugh Class C) 10. Concurrent intake of potassium sparing drugs, e.g. diuretics (amiloride and triamterene) or CPY3A4-inhibitors and ongoing potassium supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of iPTH(1-84) levels from baseline after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change of 24-hour systolic and diastolic ambulatory BP levels from baseline after 8 weeks 2. Mean change of NT-pro-BNP and osteoprotegerin from baseline after 8 weeks 3. Mean change of biomarkers of bone metabolism: osteocalcin, ß-CrossLaps, bone alkaline phosphatase | — |
Countries
Austria
Outcome results
None listed