Radiofrequency Ablation vs Adrenalectomy for unilateral aldosterone-producing adenoma with hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares radiofrequency ablation (RFA) to adrenalectomy for patients with unilateral aldosterone-producing adenoma and hypertension. The goal is to determine if RFA is not worse than adrenalectomy in normalizing hormonal endpoints at 3 months. Participants will have unilateral adrenal adenoma, confirmed primary aldosteronism, and hypertension, and will undergo either RFA or surgical removal of the adrenal adenoma. A cost-effectiveness analysis will also be performed to evaluate economic impact. The trial is led by University Hospital, Toulouse, with site-specific procedures and follow-up aligned to standard post-procedure monitoring.

Why it matters

Who can join: the full rules

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 adrenal tumours
* contralateral or bilateral macronodular adrenal hyperplasia
* no documented primary aldosteronism
* Cushing's syndrome or pheochromocytoma
* adrenal tumour \> 4 cm
* refusal to perform adrenal catheterisation if age \> 35 years
* double anti-platelet aggregation, coagulation disorders or patients treated with anticoagulant treatment that cannot be stopped
* contraindication to anaesthesia
* excessive proximity to sensitive adjacent organs
* patient who has had a heart attack or stroke within the last 6 months
* allergy to iodine
* renal insufficiency defined as a clearance of \<30 ml/min
* refusal to undergo radiofrequency ablation or adrenal surgery
* 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
* person taking part or having taken part in other interventional research in the previous 6 months
* any other relevant exclusion criteria as determined by the investigator

Where it's running

• University Hospital of Toulouse
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Bérengère BACHELET
• Email: bachelet.b@chu-toulouse.fr
• Phone: 0561322719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.