An interventional study of RFA -radiofrequency ablation and Adrenalectomy in Primary Aldosteronism Due to Conn Adenoma, Radiofrequency Ablation Treatment and Adrenalectomy, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
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.
19 studies on the registry are indexed under Adrenocortical Adenoma; 7 are open to participants now.
This study's planned enrollment of 134 is above the median of 55 across 10 interventional studies indexed under Adrenocortical Adenoma.
Browse Adrenocortical Adenoma studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with primary aldosteronism would be treated by RFA using needle electrodes
Procedure: RFA -radiofrequency ablation
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
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 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
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)
Time frame: 3 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 6 months
length of stay
Number of days of hospitalisation
Time frame: 6 months
Health economic criterion
Direct medical, non-medical costs and costs related to absence from the workplace
Time frame: 6 months
Plan to share: No
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