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RecruitingNCT05765786Updated Sep 8, 2026

Diagnosing Variable Primary Aldosteronism.

An observational study in Primary Aldosteronism and High Blood Pressure, sponsored by Queen Mary University of London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Queen Mary University of London · Observational

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The main questions it aims to answer are:

  • Can we diagnose more people if we used 24 hour urine measurements?
  • In those with high amounts of aldosterone in their urine, is there a variable pattern to their aldosterone production?

Participants will have a 24 hour urine measurement. They will also have multiple blood tests throughout the day to study the variability in aldosterone secretion.

02

Conditions studied

  • Primary Aldosteronism
  • High Blood Pressure
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.

Browse Queen Mary University of London studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with hypertension.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
  • People on end of life treatment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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?

    Time frame: 12 months

Secondary outcomes

  1. Differences in timed day and night urine THA measurements.

    We will be measuring the 24 hour urine THA samples in two separate (approximately 12 hours each) collections, one in the day and one at night. We can then study if there are any differences between day time and night time secretion which may help us understand the diurnal variation in aldosterone secretion.

    Time frame: 12 months

  2. Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.

    This will allow us to study further if the reason why their screening blood test did not meet the threshold for diagnosis.

    Time frame: 12 months

  3. Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy

    Complete clinical cure is daytime home or ambulatory BP \< 135/\<85mmHg, on no treatment. Partial clinical cure is BP \< 135/\<85 mmHg on the same or fewer drugs, not including a K+-sparing diuretic.

    Time frame: 12 months

  4. Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.

    This is defined as (whilst off medications that might alter serum potassium or the RAS) by both: 1. normalization of serum potassium and normalization of ARR or 2. elevated ARR and either baseline PAC \<190pmol/L, or normal confirmatory test (saline infusion test or captopril challenge test).

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Jul 2027, 52 months after the start.

Of 64 non-industry observational studies under Hyperaldosteronism, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 96. This study's planned 52 months is below that.

Counting every sponsor, half of 64 studies reached it within 75 months; a quarter within 32 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2023
First posted
Mar 13, 2023
StartActual
Feb 24, 2023
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 24, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05765786
Lead sponsor
Queen Mary University of London
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Feb 24, 2023
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 24, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Yun Ni Lee
Contact
y.n.lee@qmul.ac.uk
+442078827275
Tumi Kaminskas
Contact
research.governance@qmul.ac.uk
+442078827275
William Drake, Prof
principal investigator · Queen Mary University of London

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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