Primary AldosteronismNCT05765786
Diagnosing Variable Primary Aldosteronism.
An observational study of Primary Aldosteronism and High Blood Pressure, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism, High Blood Pressure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2023to 24 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with hypertension.
Who may be able to join
- 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.
Who cannot join
- Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
- People on end of life treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Mary University of London
London
Yun Ni Lee, y.n.lee@qmul.ac.uk
About this study
Official title: Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
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.
- Conditions
- Primary Aldosteronism, High Blood Pressure
- Medical subject headings
- Hyperaldosteronism, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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:
- normalization of serum potassium and normalization of ARR or
- elevated ARR and either baseline PAC <190pmol/L, or normal confirmatory test (saline infusion test or captopril challenge test).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start24 Feb 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion24 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Drake, Prof, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765786
- Sponsor's protocol ID
- 318689
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
- ClinicalTrials.gov ID
- NCT05765786
- Acronym / sponsor ID
- 318689
- Conditions
- Primary Aldosteronism, High Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 24 Jul 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with hypertension.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
- People on end of life treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.
Time frame: 12 months
Can measurement of 24 hour urine tetrahydroaldosterone excretion detect more people with PA than current conventional screening tests?
4 secondary outcomes
Differences in timed day and night urine THA measurements.
Time frame: 12 months
Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.
Time frame: 12 months
Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy
Time frame: 12 months
Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Related trials for Primary Aldosteronism
Recruiting
[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
Primary Aldosteronism
RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
Recruiting
Comparing Inclisiran Versus Statin for Primary Aldosteronism
Primary Aldosteronism
Active, not recruitingPhase 3
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Primary Hyperaldosteronism
RecruitingPhase 4
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Primary Aldosteronism, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Drake, Prof principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and High Blood Pressure, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Ni Lee (+442078827275, y.n.lee@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.