Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGöteborg University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with confirmed unilateral PA
Age 18-70 years
Candidate for surgical treatment
No contraindications for minimally invasive surgery or treatment with MRA
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Unilateral adrenalectomy
Procedure/SurgeryMinimally 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)
DrugThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Surgically Treated Primary AldosteronismActive comparator 1 intervention
Group B: Medically Treated Unilateral Primary AldosteronismActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life (QoL) evaluated with EuroQol-5D at 12 months
Improvement in quality of life in surgically and medically treated patients 1 year after treatment of unilateral primary aldosteronism evaluated with EuroQol-5D (EQ-5D-5LTM)
Time frame
1 year2
Quality of Life (QoL) evaluated with RAND SF-36 at 12 months
Improvement in quality of life in surgically and medically treated patients 1 year after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.
Time frame
1 year3
Quality of Life (QoL) evaluated with EuroQol-5D at 24 months
Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with EuroQol-5D (EQ-5D-5LTM)
Time frame
2 years4
Quality of Life (QoL) evaluated with RAND SF-36 at 24 months
Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.
Time frame
2 yearsSecondary outcomes
1
Clinical outcome based on the Primary Aldosteronism Surgical Outcome (PASO) Criteria
To evaluate treatment effects. The proportion of patients with complete, partial or absent clinical success according to the PASO criteria
Time frame
1 year2
Biochemical outcome based on the Primary Aldosteronism Surgical Outcome (PASO) Criteria
To evaluate treatment effects. The proportion of patients with complete, partial or absent biochemical success according to the PASO criteria.
Time frame
1 year3
Left ventricular mass
To evaluate treatment effects in left ventricular mass by utilizing echocardiography at 12 months
Time frame
1 year4
Left ventricular mass
To evaluate treatment effects in left ventricular mass by utilizing echocardiography at 24 months
Time frame
2 yearSponsors and contacts
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Source ClinicalTrials.gov