Exploring metabolomics for diagnosing primary aldosteronism
Pilot Untargeted Metabolomics for Primary Aldosteronism in Plasma (PUMPAP)
This study is trying to see if analyzing blood samples can help doctors better diagnose primary aldosteronism in people with high blood pressure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Liverpool University Hospitals NHS Foundation Trust Government |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT06076473 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of untargeted metabolomics in diagnosing primary aldosteronism (PA), a condition often linked to secondary hypertension. It will recruit 40 participants, including 20 with confirmed PA and 20 with other causes of hypertension, to donate lithium heparin plasma for analysis. The study will utilize existing clinical data and plasma samples to identify metabolic profiles associated with PA. The goal is to improve diagnostic protocols and potentially streamline the identification of patients who require surgical intervention versus medical management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with sustained high blood pressure and specific conditions related to hypertension being screened for primary aldosteronism.
Not a fit: Patients under 18 years old or those not undergoing screening for primary aldosteronism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and efficient diagnostic methods for primary aldosteronism, improving patient outcomes.
How similar studies have performed: While there is evidence supporting the use of targeted steroid panels in diagnosing PA, the application of untargeted metabolomics in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Subset of people being screened for PA who are eligible for inclusion in this study: * 18 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. Exclusion Criteria: * 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.
Where this trial is running
Liverpool, Merseyside
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sarah Davies, MChem MSc — Liverpool University Hospitals NHS Foundation Trust
- Study coordinator: Sarah Davies, MChem MSc
- Email: sarah.davies@liverpoolft.nhs.uk
- Phone: 0151 706 4245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.