Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment
Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial
Göteborg University
80 participants
Apr 28, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patients with confirmed unilateral PA
- Age 18-70 years
- Candidate for surgical treatment
- No contraindications for minimally invasive surgery or treatment with MRA
- Understands oral and written information and provides oral and written informed consent.
Exclusion Criteria4
- Unwilling or unable to undergo surgery
- Unwilling to accept medical treatment for 12 months and not receiving standard treatment (surgery)
- Impaired renal function with eGFR <45 ml/min/1,73m2
- P-cortisol >138 nmol/L following 1-mg overnight dexamethasone suppression test.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05797558