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

NCT07470580 | Recruiting DMC

• 2 other identifiers: RC31/24/03232024-A02225-42
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Aldosteronism Due to Conn Adenoma; Radiofrequency Ablation Treatment; Adrenalectomy

Keywords

Primary aldosteronism; hypertension; hypokalaemia; aldosterone-to-renin ratio; Aldosterone-producing adenoma; Conn syndrome; radiofrequency ablation; adrenalectomy

Outcome Measures

Primary Outcomes (1)

• aldosterone-to-renin ratio (ARR) after 15min in the sitting position

  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)

  3 months

Secondary Outcomes (14)

• Clinical success at 3 months

  3 months

• Clinical success at 6 months

  6 months

• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up

  1 month

• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up

  3 months

• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up

  6 months

Study Arms (2)

Patient treated by RFA -radiofrequency ablation

EXPERIMENTAL

patients with primary aldosteronism would be treated by RFA using needle electrodes

Procedure: RFA -radiofrequency ablation

Patients treated by adrenalectomy

ACTIVE COMPARATOR

Patients with primary aldosteronism would be treated by adrenalectomy. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients.

Procedure: Adrenalectomy

Interventions

RFA -radiofrequency ablation PROCEDURE

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

Patient treated by RFA -radiofrequency ablation

Adrenalectomy PROCEDURE

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

Patients treated by adrenalectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Adrenocortical Adenoma; Hyperaldosteronism; Hypertension; Hypokalemia

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Vascular Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Bérengère BACHELET

CONTACT

0561322719; bachelet.b@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)