An observational study in Hypertension, Primary Aldosteronism and Urine Aldosterone, sponsored by Dr Ian B Wilkinson. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Dr Ian B Wilkinson · Observational
This is an observational study compares the positivity rates of two tests for screening for primary aldosteronism: plasma aldosterone renin ratio and 24-hour urine aldosterone in patients with young-onset hypertension with or without other clinical features of primary aldosteronism.
Plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. Aldosterone secretion is not constant and may be subject to diurnal variation. As such one-off testing of ARR, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. The value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. This pilot observational study will help establish the positivity rates of both standard plasma aldosterone renin ratio and 24-hour urine aldosterone, and the degree to which they correlate but will help establish if untargeted screening in young-onset hypertension is feasible and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 120 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Dr Ian B Wilkinson is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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To enable the inclusion of a diverse population, representative of the UK in terms of ethnicity, and geographical and environmental factors that affect blood pressure and PA, we aim to conduct the study at several specialist hypertension sites in the UK. We will recruit patients referred to one of the study sites with hypertension (NICE definition) who fall into one of the following groups (cohorts):
Cohort 1: Adult patients (18-75 years of age) with onset hypertension (≤60 years of age) but without other obvious features of PA Cohort 2: Adult patients (18-75 years of age) with onset hypertension (≤60 years of age) with one of the features: low serum potassium, or resistant hypertension.
A patient will be eligible for inclusion in this trial only if all of the following criteria apply:
Exclusion Criteria:
Severe hypertension (sustained blood pressure of >200/110 mmHg) or a history of known secondary hypertension other than PA.
Rates of positive and negative, Aldosterone renin ratio and 24-hr urine aldosterone in unselected patients with hypertension and in patients with suspected primary aldosteronism
Time frame: 1 year
Degree of agreement between a positive/negative ARR and a positive/negative 24-hr urine aldosterone
Time frame: 1 year
Number of patients who required oral salt loading
Time frame: 1 year
The predictive value of a positive aldosterone renin ratio or 24-hr urine aldosterone with a positive confirmatory test
Time frame: 1 year
Plan to share: No
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Dr Ian B Wilkinson