Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)

NCT07297745 | Not Yet Recruiting

• 1 other identifier: TARGET-PA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hyperaldosteronism; Primary; Primary Aldosteronism Due to Aldosterone Producing Adenoma

Keywords

Hybrid hormone; Subtyping; adrenalectomy; adrenal vein sampling; biomarkers; steroid profiling

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (3)

• 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.

  6 months

• 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

  6 months

• Diagnostic criteria using hybrid hormones/ steroid profiling coupled with computed tomography imaging

  6 months

Study Arms (1)

Hybrid hormones

EXPERIMENTAL

Previous studies have shown that hybrid hormones are elevated in patients with unilateral primary aldosteronism who have large, visible adenomas in their adrenal glands. These tumors harbour a somatic KCNJ5 mutation and are also most likely to be cured of hypertension after surgery. Hence, the investigators hypothesize that high hybrid hormones levels, in the presence of an adenoma on a computed tomography imaging would identify study participants who can proceed to surgery.

Diagnostic Test: Hybrid hormones

Interventions

Hybrid hormones DIAGNOSTIC_TEST

Participants 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.

Hybrid hormones

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide written informed consent.

Sponsors & Collaborators

• Changi General Hospital: lead
• Singapore General Hospital: collaborator
• Sengkang General Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (4)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Sengkang General Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Troy Puar, FRCP, PhD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy H Puar, FRCP, PhD

CONTACT

67888833; troy_puar@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will prospectively recruit participants with primary aldosteronism who are keen for surgery if unilateral disease is diagnosed. Participants will undergo both routine subtyping (adrenal vein sampling and/or molecular imaging) and research subtyping (blood tests for hybrid hormone coupled with computed tomography). All results will be reviewed at a multi-disciplinary meeting, with computed tomography discussed first (radiologist will be masked to results of hybrid hormones and adrenal vein sampling), then hybrid hormones, then adrenal vein sampling. Participants with either adrenal vein sampling lateralization, or elevated hybrid hormones with a unilateral adrenal nodule and normal contralateral gland on computed tomography will be offered surgery. All participants will be re-evaluated post-surgery for biochemical cure of primary aldosteronism (co-primary outcome). Genetic sequencing will be performed on resected adrenals for KCNJ5 mutation (co-primary outcome).

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (4)