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 6 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
- 6 sitesSingapore
- Study dates
- 15 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Singapore6 sites, 6 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
Khoo Teck Puat Hospital
Singapore
Niyati Jauhar, +65 6555 8000, jauhar.niyati@nhghealth.com.sg
Niyati Jauhar
- Recruiting
National University Hospital
Singapore
Ada Teo, +65 6908 2222, ada_ed_teo@nuhs.edu.sg
Ada Teo
- Recruiting
Sengkang General Hospital
Singapore
Matthew Chuah, +65 6930 5000, matthew.chuah@singhealth.com.sg
Matthew Chuah Bingfeng
- Recruiting
Singapore General Hospital
Singapore
Swee Du Soon, +65 6222 3322, swee.du.soon@singhealth.com.sg
Swee Du Soon
- Not yet recruiting
Tan Tock Seng Hospital
Singapore
Lai Tian Rui Ray, +65 6357 3078, ray.tr.lai@nhghealth.com.sg
Lai Tian Rui Ray
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, Tan Tock Seng 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
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
- ClinicalTrials.gov ID
- NCT07297745
- Acronym / sponsor ID
- TARGET-PA
- Keywords
- Hybrid hormone, Subtyping, adrenalectomy, adrenal vein sampling, biomarkers, steroid profiling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Sengkang General Hospital, National University Hospital, Singapore, Khoo Teck Puat Hospital, Tan Tock Seng Hospital
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hybrid hormones | Experimental | Diagnostic Test: Hybrid hormonesPrevious 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid hormonesParticipants 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. | Diagnostic test | Hybrid hormones |
Primary outcome
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.
Time frame: 6 months
Proportion of participants with correction of hypokalaemia and normalisation of aldosterone-renin-ratio following unilateral adrenalectomy, as per PASO criteria.
Proportion of participants with KCNJ5-mutant aldosterone producing adenoma/nodule
Time frame: 6 months
Proportion of participants with histopathology and genetic confirmation of KCNJ5-mutant aldosterone producing adenoma/nodule in resected adrenals.
3 secondary outcomes
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.
Time frame: 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
Time frame: 6 months
Diagnostic criteria using hybrid hormones/ steroid profiling coupled with computed tomography imaging
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Troy Puar, FRCP, PhD principal investigator
Changi General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid hormones in people with Hyperaldosteronism; Primary and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 6 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Troy H Puar, FRCP, PhD (67888833, troy_puar@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.