Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism a… (NCT07470580) | Clinical Trial Compass
RecruitingNot Applicable
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
France134 participantsStarted 2026-06-05
Plain-language summary
Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%.
More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma.
Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient over 18 years of age
* Hypertension confirmed into the previous 9 months by ABPM 24h SBP/DBP \>130 and/or/80 mmHg and/or diurnal SBP/DBP \> 135 and/or 85 mmHg and/or nocturnal SBP/DBP \>120 and/or 70 mmHg with or without antihypertensive treatment
* Diagnosis of primary aldosteronism confirmed by hormonal assays no more than 1 year before inclusion
* Presence of a unilateral adrenal nodule \<4 cm considered suggestive of a Conn's adenoma on an prior adrenal CT or MRI scan, no more than 1 year before inclusion
* Adrenal venous sampling if age \> 35 years (and according to investigator decision if age \<35 years) to look for a lateralization of secretion: cannulation was successful when adrenal/peripheral venous cortisol gradients\>2 and lateralization was assessed by comparison of right and left adrenal venous aldosterone/cortisol ratios with a cut off value\>4 ipsilateral to the nod side to define a positive lateralization of secretion (2) no more than 1 year before inclusion
* nodule accessible to RFA according to the judgement of the interventional radiologist performing radiofrequency before randomisation
* nodule accessible to surgery
* patient willing to return for 6-month follow-up
* adult patient able to read the information sheet and give consent to take part in the study
* Patients affiliated to the French Health Insurance
Exclusion Criteria:
* a negative lateralization of secretion on adrenal venous sampling
* presence of bilateral a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
aldosterone-to-renin ratio (ARR) after 15min in the sitting position