Comparing surgery and medication for treating unilateral primary aldosteronism

Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial

This study is testing whether surgery or medication is better for improving the health and quality of life of people with unilateral primary aldosteronism.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Göteborg University (other)
• Locations: 3 sites (Gothenburg and 2 other locations)
• Trial ID: NCT05797558 on ClinicalTrials.gov

What this trial studies

This prospective randomized controlled trial aims to evaluate the quality of life and effectiveness of treatment in 80 patients diagnosed with unilateral primary aldosteronism. Participants will be randomly assigned to receive either surgical treatment through unilateral adrenalectomy or medical treatment with eplerenone. The study seeks to address the limited comparisons between these two treatment approaches, particularly focusing on cardiovascular outcomes and overall health care consumption. By confirming unilateral disease through adrenal venous sampling, the trial will provide valuable insights into the best treatment options for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with confirmed unilateral primary aldosteronism who are suitable for surgical treatment.

Not a fit: Patients who are unwilling to undergo surgery or have impaired renal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidance on whether surgery or medication is more effective for patients with unilateral primary aldosteronism.

How similar studies have performed: While studies comparing surgical and medical treatments for primary aldosteronism are limited, recent meta-analyses suggest that surgical treatment may lead to better cardiovascular outcomes.

Eligibility criteria

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.

Where this trial is running

Gothenburg and 2 other locations

• 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)

Study contacts

• Principal investigator: Oskar Ragnarsson, MD — Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
• Study coordinator: Oskar Ragnarsson, MD

Conditions: Primary Hyperaldosteronism Due to Adrenal Adenoma, hyperaldosteronism, primary aldosteronism, lateralized aldosteronism, unilateral aldosteronism, eplerenone, spironolactone, randomized trial