Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension (ADERADHTA2)

Toulouse University Hospital

Status: Not yet enrolling

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

Treatments: Procedure: RFA -radiofrequency ablation; Procedure: Adrenalectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07470580

2024-A02225-42 (Other Identifier)

RC31/24/0323

Details and patient eligibility

About

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.

Full description

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 PA.

Medical therapy or adrenalectomy are the 2 options to be considered. Laparoscopic adrenalectomy (LA) has been reported to be cost-effective compared with lifelong oral administration alone in unilateral PA.

Therefore, LA is the gold standard for unilateral PA 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 BP control with an overall complication rate of 5 to 14%.

More recently, radiofrequency ablation (RFA) has been used for patients with APA with an hormonal success obtained in 92% of patients treated by umbrella-shaped needle .

RFA for hypertensive patients with APA seems to be an emerging promising alternative to surgery. . Investigator team anticipate that radiofrequency allows a hormonal success of the same order than with adrenalectomy (around 95%), with simpler follow-up than surgery.

The main objective of the study is to test the non-inferiority of radiofrequency ablation compared to adrenalectomy, among hypertensive patients with primary aldosteronism and unilateral adrenal adenoma in order to normalize hormonal endpoints at 3 months of follow-up.

Cost-effectiveness and cost-utility analysis will be conducted to assess the efficiency of radiofrequency in the frame of the project.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Patient treated by RFA -radiofrequency ablation

Experimental group

Description:

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

Treatment:

Procedure: RFA -radiofrequency ablation

Patients treated by adrenalectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Adrenalectomy