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

Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Aldosteronism Due to Conn Adenoma; Adrenalectomy; Radiofrequency Ablation Treatment
• Intervention / Treatment: Procedure: RFA -radiofrequency ablation; Procedure: Adrenalectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bérengère BACHELET; Phone Number: +33 0561322719; Email: bachelet.b@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • University Hospital of Toulouse
    • Contact: Bérengère BACHELET; Phone Number: +33 561322719; Email: bachelet.b@chu-toulouse.fr
    • Principal Investigator: Béatrice Duly-Bouhanick, MD-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient treated by RFA -radiofrequency ablation; patients with primary aldosteronism would be treated by RFA using needle electrodes	Procedure: 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
Active Comparator: Patients treated by adrenalectomy; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success at 3 months	Clinical success, defined according to PASO outcome definitions at 3 months of follow-up, assessed by ambulotary blood pressure monitoring : Complete clinical success: normal blood pressure without the aid of antihypertensive medication Partial clinical success: same blood pressure as before intervention†, with less antihypertensive medication‡ or a reduction in blood pressure with either the same amount or less antihypertensive medication; Absent clinical success: unchanged or increased blood pressure† with either the same amount or an increase in antihypertensive medication	3 months
Clinical success at 6 months	Clinical success, defined according to PASO outcome definitions at 6 months of follow-up, assessed by ambulotary blood pressure monitoring : Complete clinical success: normal blood pressure without the aid of antihypertensive medication Partial clinical success: same blood pressure as before intervention†, with less antihypertensive medication‡ or a reduction in blood pressure with either the same amount or less antihypertensive medication; Absent clinical success: unchanged or increased blood pressure† with either the same amount or an increase in antihypertensive medication	6 months
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up	Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L	1 month
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up	Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L	3 months
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up	Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L	6 months
Biochemical success at 3 months of follow-up	Biochemical success at 3 months of follow-up. Complete Biochemical success: correction of hypokalaemia (if present pre-intervention) and normalisation of the aldosterone-to-renin ratio Partial biochemical success: Correction of hypokalaemia (if present pre-intervention) and a raised aldosterone-to-renin ratio with one or both of the following (compared with pre-intervention): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-intervention confirmatory test result Absent biochemical success: Persistent hypokalaemia (if present pre-intervention) or persistent raised aldosterone-to-renin ratio, or both	3 months
mean changes in Blood Pressure values assessed by ABPM at 3 months	The mean changes in 24-hour, daytime and nocturnal Systolic BP/diastolic BP values will be assessed by ABPM between pre-inclusion and 3 months	3 months
mean changes in Blood Pressure values assessed by ABPM at 6 months	The mean changes in 24-hour, daytime and nocturnal Systolic BP/diastolic BP values will be assessed by ABPM between pre-inclusion and 6 months	6 months
normalisation of office BP at 6 months	The normalisation of office BP after 6-month of follow-up will be defined by Systolic BP/diastolic BP values <140/90 mmHg without any treatment; BP will be measured with an oscillometric method: Dynamap, used in routine care, in a sitting position after 5 minutes' rest.	6 months
The use of antihypertensive agents at 6 months after RFA and after surgery	The use of antihypertensive agents at 6 months after RFA and after surgery. The number and defined daily dose (DDD, using the last index version, https://atcddd.fhi.no/atc_ddd_index/) of antihypertensive agents will be assessed	6 months
surface area destroyed by radiofrequency	In the RFA group, at 3 months of follow-up, the surface area destroyed and preservation of the adrenal gland around will be assessed by adrenal CT scan: Patients will undergo adrenal scan without and with injection of contrast product after verification of renal function.	3 months
Number of Adverse events	Adverse events will be collected and serious adverse events reported in the 2 groups at each visit until the end of the study	6 months
length of stay	Number of days of hospitalisation	6 months
Health economic criterion	Direct medical, non-medical costs and costs related to absence from the workplace	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; hypertension; Primary aldosteronism; adrenalectomy; hypokalaemia; aldosterone-to-renin ratio; Aldosterone-producing adenoma; Conn syndrome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Metabolic Diseases; Endocrine Gland Neoplasms; Water-Electrolyte Imbalance; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Nutritional and Metabolic Diseases; Hypertension; Hyperaldosteronism; Adrenocortical Adenoma; Hypokalemia; Surgical Procedures, Operative; Endocrine Surgical Procedures; Adrenalectomy
• Other Study ID Numbers: RC31/24/0323; 2024-A02225-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No