Diagnosing Variable Primary Aldosteronism.
Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
1 other identifier
observational
100
1 country
1
Brief Summary
The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2023
CompletedFirst Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 24, 2027
June 15, 2026
June 1, 2026
4.4 years
March 1, 2023
June 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.
Can measurement of 24 hour urine tetrahydroaldosterone excretion detect more people with PA than current conventional screening tests?
12 months
Secondary Outcomes (4)
Differences in timed day and night urine THA measurements.
12 months
Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.
12 months
Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy
12 months
Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.
12 months
Eligibility Criteria
People with hypertension.
You may qualify if:
- 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.
You may not qualify if:
- Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
- People on end of life treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary University of London
London, United Kingdom
Biospecimen
Urine and whole blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Drake, Prof
Queen Mary University of London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
February 24, 2023
Primary Completion (Estimated)
July 24, 2027
Study Completion (Estimated)
July 24, 2027
Last Updated
June 15, 2026
Record last verified: 2026-06