Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05405101

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

Led by Queen Mary University of London · Updated on 2026-02-23

122

Participants Needed

6

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Primary aldosteronism diagnosed according to international guidelines
  • Unilateral disease confirmed by adrenal venous sampling or PET-CT
  • Presence of ipsilateral benign adrenal abnormality suitable for both thermal ablation and surgery
  • Able and willing to give informed consent
  • Randomisation approved by multidisciplinary team
Not Eligible

You will not qualify if you...

  • Absolute contraindication to alpha- or beta-adrenoceptor antagonist therapy or CT contrast
  • Contraindication or unwillingness for either surgery or thermal ablation
  • Inability to stop beta-adrenoceptor antagonist therapy for 2 weeks
  • Unwilling to undergo laparoscopic adrenalectomy or thermal ablation
  • Unwilling to comply with study visit schedule
  • Pregnancy or unwillingness to use secure contraception during the study (for female participants)
  • Life-limiting comorbidity as judged by the principal investigator
  • Evidence of autonomous cortisol secretion requiring adrenalectomy independent of aldosterone secretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Cambridge University Hospitals NHS Foundation Trust

Cambridge, SMLG, United Kingdom, CB2 0QQ

Actively Recruiting

2

St Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Actively Recruiting

3

University College London Hospital NHS Foundation Trust

London, United Kingdom, NW1 2PG

Actively Recruiting

4

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT

Actively Recruiting

5

Imperial College Healthcare NHS Trust

London, United Kingdom, W12 0HS

Actively Recruiting

6

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

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Research Team

A

Aklima Khatun

CONTACT

T

Tumi Kaminsas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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