Diagnosing Variable Primary Aldosteronism.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
People on end of life treatment.
Trial population
People with hypertension.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 monthsSecondary 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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov