Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asy… (NCT05405101) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
United Kingdom112 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.