About this trial
The goal of this randomised open-label controlled study is to compare the biochemical and clinical responses following \[11C\]Metomidate-PET CT(MTO-PET) versus usual care with adrenal venous sampling as first lateralisation strategy in people with biochemically confirmed primary aldosteronism(PA). The main question it aims to answer is: what is the proportion of people who achieved complete or partial clinical success among those who underwent PA treatment?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Paired measurement of renin and aldosterone demonstrating a raised aldosterone-to-renin ratio >550 pmol/L/ng/mL/h AND
Suppressed renin <=1ng/ml/h
1) Non-suppressed aldosterone >162pmol/L following seated saline infusion OR
2) raised 24-hour urine aldosterone >38 nmol/d following oral salt loading test (17)
Disqualifiers
Unable to give informed consent
Participants who neither agree to AVS nor MTO-PET
Patients who indicate they will not proceed to adrenalectomy
Patients contraindicated for mineralocorticoid receptor antagonists
Trial design
Parallel
Treatments tested in this trial
[11C] Metomidate PETCT
Procedure/SurgeryMetomidate labelled with C11H3(\[11C\]Metomidate) is used as a radiotracer in PET-CT to detect expression of CYP11B1 and CYP11B2 in adrenal cortex.
Adrenal Venous Sampling
Procedure/SurgeryAdrenal venous sampling is an invasive procedure that involves insertion of a catheter to adrenal veins to determine if one side of the adrenal is producing excess aldosterone hormones compared to the other side.
Treatment groups
Trial outcomes
Primary outcomes
Compare the proportion of people who achieved complete or partial clinical success
Clinical success is defined by Primary Aldosteronism Surgical Outcome criteria for people who underwent surgery and Primary Aldosteronism Medical Treatment Outcome criteria for those who received mineralocorticoid receptor antagonist
Sponsors and contacts
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