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NCT05405101
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Conditions: Primary Aldosteronism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: Queen Mary University of London
Location: Cambridge University Hospitals NHS Foundation Trust Cambridge SMLG
Summary
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
Inclusion criteria (all of):
* 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
* Able and willing to give informed consent
* Randomisation approved by MDT
Exclusion criteria (any of):
* 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
* Unwilling to comply with study visit schedule
* Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only)
* Life-limiting comorbidity (at the discretion of the PI)
* Clinical and/or biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion
Source: ClinicalTrials.gov (NCT05405101). StuddyBuddy aggregates publicly available trial information.