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Clinical Trials in Sweden / NCT05797558
Recruiting Not applicable

Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment

NCT05797558 · tracked via the Priya Life Science Sweden tracker
Sponsor
Göteborg University
Phase
Not applicable
Started
2023-04-28
Last updated
2025-04-06

Condition(s) studied

Primary Hyperaldosteronism Due to Adrenal Adenoma

Investigational drug(s) / intervention(s)

Unilateral adrenalectomyMedical treatment (eplerenone) →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with confirmed unilateral PA 2. Age 18-70 years 3. Candidate for surgical treatment 4. No contraindications for minimally invasive surgery or treatment with MRA 5. Understands oral and written information and provides oral and written informed consent. Exclusion Criteria: 1. Unwilling or unable to undergo surgery 2. Unwilling to accept medical treatment for 12 months and not receiving standard treatment (surgery) 3. Impaired renal function with eGFR \<45 ml/min/1,73m2 4. P-cortisol \>138 nmol/L following 1-mg overnight dexamethasone suppression test.

Primary outcome measure(s)

  • Quality of Life (QoL) evaluated with EuroQol-5D at 12 months — 1 year
    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)
  • Quality of Life (QoL) evaluated with RAND SF-36 at 12 months — 1 year
    Improvement in quality of life in surgically and medically treated patients 1 year after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.
  • Quality of Life (QoL) evaluated with EuroQol-5D at 24 months — 2 years
    Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with EuroQol-5D (EQ-5D-5LTM)
  • Quality of Life (QoL) evaluated with RAND SF-36 at 24 months — 2 years
    Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.

Trial sites (3)

FacilityCityRegionStatus
University of Gothenburg Gothenburg Sweden Recruiting
Karolinska University Hospital, Stockholm, Sweden. Stockholm Sweden Not Yet Recruiting
Umeå University, Umeå, Sweden. Umeå Sweden Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05797558 on ClinicalTrials.gov ↗ ← All trials in Sweden