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Primary Aldosteronism Due to Conn AdenomaADERADHTA2NCT07470580

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

A study testing RFA -radiofrequency ablation and Adrenalectomy in people with Primary Aldosteronism Due to Conn Adenoma and Radiofrequency Ablation Treatment, run by University Hospital, Toulouse at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RFA -radiofrequency ablation and Adrenalectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteFrance
Study dates
5 Jun 2026to 1 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • University Hospital of Toulouse

    Toulouse

    Bérengère BACHELET, 561322719 ext. +33, bachelet.b@chu-toulouse.fr

    Béatrice Duly-Bouhanick, MD-PH

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
RFA -radiofrequency ablation, Adrenalectomy
Keywords
Primary aldosteronism, hypertension, hypokalaemia, aldosterone-to-renin ratio, Aldosterone-producing adenoma, Conn syndrome, radiofrequency ablation, adrenalectomy
Medical subject headings
Adrenocortical Adenoma, Hyperaldosteronism, Hypertension, Hypokalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RFA -radiofrequency ablationProcedure or surgery

    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

  • AdrenalectomyProcedure or surgery

    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 groups in NCT07470580
Study groupRoleWhat they receive
Patient treated by RFA -radiofrequency ablationExperimentalpatients with primary aldosteronism would be treated by RFA using needle electrodes
Receives: Procedure: RFA -radiofrequency ablation
Patients treated by adrenalectomyActive comparatorPatients with primary aldosteronism would be treated by adrenalectomy. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients.
Receives: Procedure: Adrenalectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (14)
  1. 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

    Measured: 3 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 1 month

  4. 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

    Measured: 3 months

  5. 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

    Measured: 6 months

  6. 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

    Measured: 3 months

  7. 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

    Measured: 3 months

  8. 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

    Measured: 6 months

  9. 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.

    Measured: 6 months

  10. 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

    Measured: 6 months

  11. 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.

    Measured: 3 months

  12. 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

    Measured: 6 months

  13. length of stay

    Number of days of hospitalisation

    Measured: 6 months

  14. Health economic criterion

    Direct medical, non-medical costs and costs related to absence from the workplace

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start5 Jun 2026
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470580
Sponsor's protocol ID
RC31/24/0323
Other IDs
2024-A02225-42
Acronym
ADERADHTA2
Status last verified
Jun 2026
First submitted
10 Mar 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RFA -radiofrequency ablation and Adrenalectomy in people with Primary Aldosteronism Due to Conn Adenoma and Radiofrequency Ablation Treatment, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bérengère BACHELET (0561322719 ext. +33, bachelet.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

aldosterone-to-renin ratio (ARR) after 15min in the sitting position (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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