Hyperaldosteronism; PrimaryNCT07297745
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
A study testing Hybrid hormones in people with Hyperaldosteronism; Primary and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 4 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
- What is being tested?
- Hybrid hormones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesSingapore
- Study dates
- 15 Jan 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide written informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore4 sites, 4 recruiting
- Recruiting
Changi General Hospital
Singapore, Singapore, 529889
Troy H Puar, FRCP, PhD, +65 68503967, troy_puar@cgh.com.sg
Troy H Puar, FRCP, PhD
- Not yet recruiting
National University Hospital
Singapore
Ada Teo, 6908 2222, ada_ed_teo@nuhs.edu.sg
- Not yet recruiting
Sengkang General Hospital
Singapore
Matthew Chuah, 6930 5000, matthew.chuah@singhealth.com.sg
- Not yet recruiting
Singapore General Hospital
Singapore
Swee Du Soon, 6222 3322, swee.du.soon@singhealth.com.sg
About this study
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.
Read the detailed description
Primary Aldosteronism is a common but under-diagnosed condition, despite being a curable cause of secondary hypertension with significant long-term health consequences if left untreated. Once the diagnosis of primary aldosteronism is confirmed, subtype tests are required to demonstrate unilateral primary aldosteronism before curative surgery. Most patients need to undergo adrenal vein sampling, an invasive procedure performed under radiological guidance. However, this procedure is technically-challenging, with failure to cannulate both adrenal veins frequently leading to inconclusive results. Many patients worldwide may be offered surgery based on computed tomography imaging alone because of a lack of adrenal vein sampling expertise or a failed adrenal vein sampling result.
High hybrid hormones indicate a functional KCNJ5-mutant aldosterone-producing adenoma and, when coupled with computed tomography imaging, may provide a non-invasive alternative to adrenal vein sampling for identifying unilateral primary aldosteronism.
Ultimately, this trial aims to reduce the number of patients that will require an invasive adrenal vein sampling in future clinical diagnostics. This will improve access, and allow more patients to receive timely and curative treatment.
- Being tested
- Hybrid hormones
- Keywords
- Hybrid hormone, Subtyping, adrenalectomy, adrenal vein sampling, biomarkers, steroid profiling
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid hormonesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Hybrid hormones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Proportion of participants with reduction in blood pressure and reduction anti-hypertensive medication following unilateral adrenalectomy, as per PASO criteria.
Measured: 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
Cost-effectiveness of the diagnostic course will be calculated by using calculated costs per quality-adjusted life years (QALYs)
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperaldosteronism; PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Sengkang General Hospital, National University Hospital, Singapore, Khoo Teck Puat Hospital
- Responsible party
- Sponsor
- Investigators
- Troy Puar, FRCP, PhD, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297745
- Sponsor's protocol ID
- TARGET-PA
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No