Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension

NCT07470580 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Not applicable

Started

2026-06-05

Last updated

2026-06-11

Condition(s) studied

Primary Aldosteronism Due to Conn AdenomaRadiofrequency Ablation TreatmentAdrenalectomy

Investigational drug(s) / intervention(s)

RFA -radiofrequency ablationAdrenalectomy

RFA -radiofrequency ablation: Under real-time multidetector CT-guidance, the patients will be put in either prone or lateral decubitus position to choose for the optimal access route for RFA needle electrode. Under multidetector CT guidance, patients would be treated with regard to optimal RFA needle access route with a hydrodissection or aero dissection if necessary. 2 types of generator (Boston Scientific RF 3000, and Ablatech Amica) and of needle electrodes (Leveen-type extendable, Ablatech) will be used according to the routine care of the centers

Adrenalectomy: Adrenalectomy may be performed using a laparoscopic or open approach. In either approach, the gland may be approached transabdominally or retroperitoneally. The choice of surgical approach depends on the size and nature of the lesion, the patient's general characteristics and the expertise of the surgeon. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

aldosterone-to-renin ratio (ARR) after 15min in the sitting position — 3 months
aldosterone-to-renin ratio (ARR) after 15 min in the sitting position. Following the recommendations given by Douillard et al (15), normalisation of the ARR will be defined (according to the measurement method) using: * a cut-off value of the ARR of 23 (plasma aldosterone in pg/mL and direct renin in mIU/l) or 64 (plasma aldosterone in pmol/L and direct renin in mIU/l) * a cut-off value of the ARR of 300 (plasma aldosterone in pg/mL and PRA in ng/mL/h), or 830 (plasma aldosterone in pmol/L and PRA in ng/mL/h), or 25 (plasma aldosterone in pg/mL and PRA in pmol/L/min), or 70 (plasma aldosterone in pmol/l and PRA in pmol/L/min). (8,15) * a cut-off value of the ARR of 46 (plasma aldosterone in pmol/l in Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and renin in mU/l) (16)

Trial sites (1)

Facility	City	Region	Status
University Hospital of Toulouse	Toulouse	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07470580 on ClinicalTrials.gov ↗ ← All trials in France