Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorChangi General Hospital
About this trial
The goal of this project is to improve the diagnostic pathway for patients with primary aldosteronism, by validating non-invasive biomarkers coupled with routine computed tomography imaging. The aim is to reduce reliance on invasive procedures, shorten diagnostic timelines, and enhance accessibility to definitive diagnosis and treatment globally.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of primary aldosteronism according to the Endocrine Society guideline 2025.
Willing to undergo subtype testing with adrenal vein sampling and/or molecular imaging (Positron Emission Tomography/Computed Tomography, PET/CT).
Keen for surgical treatment if shown to have unilateral primary aldosteronism.
Disqualifiers
Inability to provide written informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
Hybrid hormones
Diagnostic testParticipants will have a baseline blood sample taken so the investigators can measure the adrenal steroid biomarkers 18-oxocortisol, 18-hydroxylcortisol and other steroids. The collected plasma or serum will then be analyzed in the laboratory using validated methods, such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), to determine the levels of these biomarkers.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Hybrid hormonesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with complete biochemical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy.
Proportion of participants with correction of hypokalaemia and normalisation of aldosterone-renin-ratio following unilateral adrenalectomy, as per PASO criteria.
Time frame
6 months2
Proportion of participants with KCNJ5-mutant aldosterone producing adenoma/nodule
Proportion of participants with histopathology and genetic confirmation of KCNJ5-mutant aldosterone producing adenoma/nodule in resected adrenals.
Time frame
6 monthsSecondary outcomes
1
Proportion of participants with complete clinical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy.
Proportion of participants with reduction in blood pressure and reduction anti-hypertensive medication following unilateral adrenalectomy, as per PASO criteria.
Time frame
6 months2
Cost-effectiveness of using hybrid hormones coupled with computed tomography imaging versus other subtyping tests including adrenal vein sampling and/or molecular imaging in diagnosing participants with unilateral primary aldosteronism
Cost-effectiveness of the diagnostic course will be calculated by using calculated costs per quality-adjusted life years (QALYs)
Time frame
6 months3
Diagnostic criteria using hybrid hormones/ steroid profiling coupled with computed tomography imaging
The criteria of hybrid hormones/ steroid profiling coupled with computed tomography imaging which offer the best sensitivity and specificity for lateralization of aldosterone-producing adenoma.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Changi General Hospital
Lead sponsor
Singapore General Hospital
Collaborator
Sengkang General Hospital
Collaborator
National University Hospital, Singapore
Collaborator
Khoo Teck Puat Hospital
Collaborator
Source ClinicalTrials.gov