Diagnosing Variable Primary Aldosteronism
Official title: Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
Run by Queen Mary University of London · NCT05765786 · Data updated 2026-11-12
This study is testing if measuring aldosterone levels in urine over 24 hours can help doctors better diagnose people who might have Primary Aldosteronism.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | February 24, 2023 |
| Main results expected | July 1, 2027 |
| Study ends | July 24, 2027 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05765786 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with clinically suspected Primary Aldosteronism who have not yet met diagnostic criteria, as well as those previously diagnosed with PA but with aldosterone levels that are typically not qualifying for confirmatory testing.
✕Probably not a fit
Patients who are unable to withdraw from β-adrenoceptor antagonist therapy or those receiving end-of-life treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the patterns of aldosterone production in individuals suspected of having Primary Aldosteronism (PA). Participants will undergo 24-hour urine measurements and multiple blood tests throughout the day to assess the variability in aldosterone secretion. The study seeks to determine if using 24-hour urine measurements can help diagnose more cases of PA and if there is a cyclical or exaggerated diurnal variation in aldosterone levels among those with high urinary aldosterone. The findings could enhance diagnostic accuracy for PA.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for Primary Aldosteronism, allowing for earlier and more accurate identification of affected patients.
How similar studies have gone: While this approach is observational and may build on existing knowledge, it is focused on a specific aspect of aldosterone variability that has not been extensively tested in this manner.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity \<0.5 nmol/h/L or renin mass \<5 ng/L), plasma sodium \> 140mmol/L or plasma potassium \< 4mmol/L. * Patients who have been diagnosed with PA and had previous aldosterone samples \<277 pmol/L, a level which would normally not qualify for confirmatory testing. * Patients with aldosterone results done at different times that indicate variability in production. * Willing to consent and participate in the study. Exclusion Criteria: * Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks. * People on end of life treatment.
Where it's running
-
Queen Mary University of London
London, United Kingdom Recruiting
Study contacts
- Principal investigator: William Drake, Prof — Queen Mary University of London
- Study coordinator: Yun Ni Lee
- Email: y.n.lee@qmul.ac.uk
- Phone: +442078827275
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.