Diagnosing Variable Primary Aldosteronism.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Aldosteronism, High Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
Overview
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.
Primary outcome measures
- Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion. [Time frame: 12 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Queen Mary University of London — London
Identifiers
NCT: NCT05765786 · 318689