A prospective randomised trial comparing radiofrequency ablation With laparoscopic Adrenalectomy as an alternatiVE treatment for unilateral primary aldosteronism (WAVE)

Of 12M people in the UK with hypertension, 5-10% have primary aldosteronism (PA).

Cardiac morbidity (atrial fibrillation, heart failure) in PA patients is twice that in essential hypertension; this combination of prevalence and penalty mandates detection, investigation and treatment of PA. ~50% of cases are caused by a single, potentially resectable aldosterone producing adenoma (APA).

At present <​1% of cases are investigated and treated.

The reasons include surgical capacity, uncertain surgical outcomes, and physician/patient reluctance to recommend/undergo resection of an entire gland as treatment for a small, benign tumour. Retrospective reports of radiofrequency ablation (RFA) or APAs suggest a promising solution to these issues.

We propose a PROBE (Prospective, Randomised, Open-label with Blind Endpoint) multi-centre comparison of RFA with laparoscopic adrenalectomy (LA) in the treatment of APA.

Recent international consensus on definition, and respective likelihood, of biochemical and clinical cure following LA permits rigorous, hierarchical primary endpoints and robust sample-size calculation.

In 110 patients with PA and a unilateral APA, we hypothesize that RFA will be non-inferior to LA in curing PA and hypertension, and superior in measures of morbidity and time-off-work. WAVE can transform management of PA, and substantially improve outcomes in a large number of hypertensive patients.