Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Mary University of London

About this trial

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria.

Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought.

* Frequency and severity of adverse events * Length of inpatient stay * Patient satisfaction * Quality of life * Return to activities of daily living

An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

Eligibility criteria

Qualifiers

Age > 18 years

Primary aldosteronism diagnosed according to international guidelines

Unilateral disease by AVS or PET-CT criteria

Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery

Disqualifiers

Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast

Contraindication or unwillingness for either surgery or thermal ablation

Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks

Unwilling to undergo either LA or thermal ablation

Trial design

Treatments tested in this trial

  • Thermal ablation of aldosterone producing adenoma.
  • Unilateral adrenalectomy

Treatment groups

122 Participants
are divided into 2 treatment groups