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Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment
Sponsor: Göteborg University
Summary
This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism ,randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone.
Official title: Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-04-28
Completion Date
2028-05-28
Last Updated
2025-04-06
Healthy Volunteers
No
Interventions
Unilateral adrenalectomy
Minimally invasive surgery is performed via the lateral transperitoneal approach or the posterior retroperitoneal approach, with or without robotic assistance, according to the surgeon's preference.
Medical treatment (eplerenone)
The initial dose of eplerenone is 25 mg twice daily. The dose will be increased by 50 mg every fourth week until systolic blood pressure of 140 mmHg and diastolic blood pressure of 90 mmHg or lower has been reached and biochemical control (plasma renin above the middle of the reference range, i.e \> \~20 mIU/L) is attained and/or hyperkalemia develops. The maximal dose of eplerenone is 300 mg twice daily.
Locations (3)
University of Gothenburg
Gothenburg, Sweden
Karolinska University Hospital, Stockholm, Sweden.
Stockholm, Sweden
Umeå University, Umeå, Sweden.
Umeå, Sweden