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

Launched by QUEEN MARY UNIVERSITY OF LONDON · May 31, 2022

Keywords

ClinConnect Summary

The WAVE trial is a study comparing two treatments for a condition called primary aldosteronism, which can cause high blood pressure and other health issues. Specifically, the trial is looking at whether a less invasive procedure called thermal ablation (using heat to destroy the overactive adrenal tissue) is as effective as traditional surgery (adrenalectomy) for treating this condition. Researchers want to see if thermal ablation not only helps patients feel better and improves their health but also if it leads to fewer side effects, shorter hospital stays, and better overall satisfaction with treatment.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with primary aldosteronism. They should have a specific type of the condition that affects only one adrenal gland and be willing to provide informed consent to join the study. Participants can expect to be randomly assigned to either the thermal ablation or surgery group, and their progress will be monitored closely. It's important to note that the trial is actively recruiting participants, and individuals with certain health issues or conditions may not be eligible. This study aims to find out the best treatment for primary aldosteronism, which may help many patients in the future.

Gender

ALL

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