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NCT Number: NCT05765786

Diagnosing Variable Primary Aldosteronism.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary University of London

London, United Kingdom

Location status: Recruiting

Location contact

Yun Ni Lee

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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?

Secondary outcomes

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

    Time frame: 12 months

    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.

  2. 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

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

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

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tumi Kaminskas

CONTACT

[email protected]

+442078827275

Yun Ni Lee

CONTACT

[email protected]

+442078827275

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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