Status:
RECRUITING
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Lead Sponsor:
Queen Mary University of London
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, accor...
Detailed Description
Primary aldosteronism (PA) results from renin-independent aldosterone hypersecretion and causes hypertension, often with associated hypokalaemia and metabolic alkalosis. These are due to enhanced mine...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05405101
Start Date
September 1 2022
End Date
September 1 2026
Last Update
February 26 2025
Active Locations (6)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, SMLG, United Kingdom, CB2 0QQ
2
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
3
University College London Hospital NHS Foundation Trust
London, United Kingdom, NW1 2PG
4
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT