Diagnosing Variable Primary Aldosteronism
Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
Queen Mary University of London · NCT05765786
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05765786 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London
- 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
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.
Conditions: Primary Aldosteronism, High Blood Pressure