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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

a negative lateralization of secretion on adrenal venous sampling

presence of bilateral adrenal tumours

contralateral or bilateral macronodular adrenal hyperplasia

no documented primary aldosteronism

Trial design

Treatments tested in this trial

  • RFA -radiofrequency ablation
  • Adrenalectomy

Treatment groups

134 Participants
are divided into 2 treatment groups

Sponsors and collaborators