Untargeted Metabolomics for Primary Aldosteronism

NCT06076473 | Unknown

• 1 other identifier: LHS001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aldosteronism (PA) is a common and likely under-diagnosed cause of secondary hypertension with associated cardiovascular morbidity and mortality. Current diagnosis comprises screening, confirmatory testing and sub-type classification (lateralisation) to distinguish unilateral disease (requiring surgery) from bilateral disease (requiring medical management). This multi-step process is complex and variable with a lack of uniformity in diagnostic protocols, standardised/reference assay methodologies, and diagnostic thresholds. There is evidence in the literature that targeted serum steroid panels may have a role in diagnosis of PA, and both targeted steroid panels and untargeted metabolomics in serum and urine are a promising area of research. This study aims to identify and recruit participants (n=40; 20 with confirmed PA and 20 with other causes of hypertension) willing to donate lithium heparin plasma for a metabolomics pilot study. This plasma will be interrogated through untargeted metabolomics using gas/liquid chromatography-mass-spectrometric methods and computational data processing to allow power calculations and inform experimental design for future studies. The utility of metabolites from the metabolomics dataset will be evaluated by comparison against current biomarkers for screening, diagnosis and lateralisation as well as radiology and histology acquired through routine diagnostic work-up. The long-term aim for larger studies is to identify suitable candidate analytes in plasma for future development into targeted, clinically-useful analyte panels.

Conditions

Primary Aldosteronism

Keywords

Pilot; Untargeted Metabolomics; Primary Aldosteronism; Plasma

Outcome Measures

Primary Outcomes (1)

• Untargeted metabolomics

  Identification of candidate biomarkers

  2 years

Study Arms (2)

Confirmed Primary Aldosteronism

Confirmed Primary Aldosteronism

Diagnostic Test: Untargeted metabolomics

Non-Primary Aldosteronism

Other causes of hypertension

Diagnostic Test: Untargeted metabolomics

Interventions

Untargeted metabolomics DIAGNOSTIC_TEST

Pilot untargeted plasma metabolomics aiming to identify novel biomarkers for PA diagnosis and subtyping, which could be compared against existing biomarkers and taken forward to larger future studies.

Confirmed Primary Aldosteronism; Non-Primary Aldosteronism

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be undergoing diagnostic work-up for PA, meet the above eligibility criteria, and give informed consent to participate.

You may qualify if:

• Screening for PA to be performed in people with:
• sustained blood pressure (BP) above 150/100 mm Hg on each of three measurements obtained on different days, with hypertension (BP \>140/90 mm Hg) resistant to three conventional antihypertensive drugs (including a diuretic), or controlled BP (\<140/90 mm Hg) on four or more antihypertensive drugs.
• hypertension and spontaneous or diuretic-induced hypokalaemia.
• hypertension and adrenal incidentaloma.
• hypertension and sleep apnoea.
• hypertension and a family history of early onset hypertension or cerebrovascular accident at a young age (\<40 years).
• all hypertensive first-degree relatives of people with PA.
• years of age or older.
• People under the care of LUHFT.
• Able to give informed consent.
• Having lithium heparin plasma samples collected as part of their routine care.

You may not qualify if:

• Under 18 years of age.
• Unable to give informed consent.
• Insufficient clinical/biochemical/radiological/histological information to accurately assign patients to PA or non-PA subsets.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surplus lithium heparin samples collected as part of routine care will be stored prior to analysis and used to destruction during analysis. Spare aliquots for data validation will be stored until the end of the study period (2 years) and then discarded in line with standard laboratory protocols.

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Sarah Davies, MChem MSc

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Davies, MChem MSc

CONTACT

0151 706 4245; sarah.davies@liverpoolft.nhs.uk

Andrew Davison, BSc MSc PhD

CONTACT

0151 706 4011; andrew.davison@liverpoolft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: October 10, 2023
• Study Start: January 19, 2023
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2025
• Last Updated: February 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)