Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism
NCT ID: NCT07297745
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2026-01-02
2029-12-31
Brief Summary
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Detailed Description
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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 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.
We will have dual primary outcomes:
1. To determine the sensitivity of hybrid hormones combined with computed tomography imaging in identifying unilateral primary aldosteronism.
2. To determine the specificity of hybrid hormones combined with computed tomography imaging in identifying KCNJ5-mutant aldosterone-producing adenomas.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
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. Patients 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 patients 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).
DIAGNOSTIC
NONE
Study Groups
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Hybrid hormones
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, we hypothesize that high hybrid hormones levels, in the presence of an adenoma on a computed tomography imaging would identify patients who can proceed to surgery.
Hybrid hormones
Participants will have a baseline blood sample taken so we can measure the adrenal steroid biomarkers 18-oxocortisol and 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.
Interventions
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Hybrid hormones
Participants will have a baseline blood sample taken so we can measure the adrenal steroid biomarkers 18-oxocortisol and 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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Sengkang General Hospital
OTHER
National University Hospital, Singapore
OTHER
Changi General Hospital
OTHER
Responsible Party
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Principal Investigators
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Troy Puar, FRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
Changi General Hospital
Locations
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Changi General Hospital
Singapore, Singapore, Singapore
National University Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Troy H Puar, FRCP, PhD
Role: primary
Ada Teo
Role: primary
Matthew Chuah
Role: primary
Swee Du Soon
Role: primary
Other Identifiers
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TARGET-PA
Identifier Type: -
Identifier Source: org_study_id