Diagnosing Variable Primary Aldosteronism.

Recruiting

• Conditions: Primary Aldosteronism; High Blood Pressure

• Registration Number: NCT05765786
• Lead Sponsor: Queen Mary University of London

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.

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 Timeline

• Study Start: 2023-02-24
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2026-02-24
• Study Completion: 2026-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.	12 months	Can measurement of 24 hour urine tetrahydroaldosterone excretion detect more people with PA than current conventional screening tests?

Secondary Outcome Measures

Name	Time	Method
Differences in timed day and night urine THA measurements.	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.
Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.	12 months	This will allow us to study further if the reason why their screening blood test did not meet the threshold for diagnosis.
Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.	12 months	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).
Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy	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.

Trial Locations

Locations (1)

Queen Mary University of London; 🇬🇧 London, United Kingdom