Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Recruiting · NCT07470580 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
1 location listed.
- University Hospital of Toulouse - Toulouse, France