Comparing surgery and medication for treating unilateral primary aldosteronism
Official title: Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial
Run by Göteborg University · NCT05797558 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Göteborg University Academic / other |
| Locations | 3 sites (Gothenburg and 2 other locations) |
| Status | Recruiting |
| Started | April 28, 2023 |
| Main results expected | May 28, 2028 |
| Study ends | May 28, 2028 |
| Registry record updated | April 6, 2025 |
| Trial ID | NCT05797558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with confirmed unilateral primary aldosteronism who are suitable for surgical treatment.
✕Probably not a fit
Patients who are unwilling to undergo surgery or have impaired renal function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: oskar.ragnarsson@medic.gu.se
- Phone: 00460313421000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Quality of life during adjuvant immunotherapy for locally advanced non-small cell lung cancer
This study looks at how patients feel and cope during a year of immunotherapy after chemoradiotherapy for locally advanced non-small cell lung cancer.
-
Health effects of ultra-processed foods on appetite and cardiometabolic health
This study tests whether a high ultra-processed food diet affects appetite and cardiometabolic health compared with a nutrient-matched low ultra-processed diet in adults who keep their weight stable.
-
Life-sustaining care decisions in critically ill children
This study looks at how decisions about withholding or withdrawing life-sustaining treatments are made for critically ill children in intensive care.
-
Short-term effects of ultra-processed foods on metabolism
This project will test whether a short-term diet high in ultra-processed foods versus a nutrient- and energy-matched low-UPF diet changes appetite and how much adults with BMI 18.5–30 eat.
-
Digital program to help teenagers transition from pediatric to adult healthcare
This study is testing a new online program to help teenagers with asthma and organ transplants smoothly move from children's to adult healthcare and see if it works better than regular in-person care.
-
Evaluating mobilization and breathing exercises after abdominal surgery
This study is testing a new recovery plan that includes getting up and moving around sooner and doing breathing exercises to see if it helps patients recover faster after abdominal surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.