NCT07470580Recruiting
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 5 Jun 2026
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- High blood pressure
- NCT number
- NCT07470580
What you commit to
- Study type: Interventional
- Planned participants: 134
- From 5 Jun 2026 to the primary completion date, 1 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- refusal to undergo radiofrequency ablation or adrenal surgery
- person taking part or having taken part in other interventional research in the previous 6 months
Other illness
- Cushing's syndrome or pheochromocytoma
- patient who has had a heart attack or stroke within the last 6 months
- allergy to iodine
Lab values
- double anti-platelet aggregation, coagulation disorders or patients treated with anticoagulant treatment that cannot be stopped
- renal insufficiency defined as a clearance of \<30 ml/min
Age
- refusal to perform adrenal catheterisation if age \> 35 years
Other
- a negative lateralization of secretion on adrenal venous sampling
- presence of bilateral adrenal tumours
- contralateral or bilateral macronodular adrenal hyperplasia
- no documented primary aldosteronism
- adrenal tumour \> 4 cm
- contraindication to anaesthesia
- excessive proximity to sensitive adjacent organs
- minors and patients under guardianship, curatorship or safeguard of justice
- Inability to speak, read or write French fluently
- patients who refuse follow-up
- pregnant women or women wishing to become pregnant in the short term; breast-feeding
- any other relevant exclusion criteria as determined by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.