Diagnosing Variable Primary Aldosteronism.

NCT ID: NCT05765786

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-24

Study Completion Date

2026-02-24

Brief Summary

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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

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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

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Primary Aldosteronism High Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Drake, Prof

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Queen Mary University of London

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Yun Ni Lee

Role: CONTACT

+442078827275

Tumi Kaminskas

Role: CONTACT

+442078827275

Facility Contacts

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Yun Ni Lee

Role: primary

Other Identifiers

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318689

Identifier Type: -

Identifier Source: org_study_id

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