PURL, Version1.0
Research type
Research Study
Full title
Screening for Primary aldosteronism in hypertension with 24-hour URinary aLdosterone: A pilot study
IRAS ID
329210
Contact name
Ian B. Wilkinson
Contact email
Sponsor organisation
Cambridge University NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Primary aldosteronism is considered a common secondary cause of hypertension and it occurs due to the unregulated secretion of a hormone called aldosterone which in turn leads to a rise in blood pressure. Approximately, 5-10% of patients presenting with hypertension, may have underlying primary aldosteronism. The diagnosis relies on the results of screening tests which is a randomly taken blood test sample. It is possible that the current screening strategy may be not adequately robust enough to rule out primary aldosteronism in all patients with hypertension and this study aims to check if an available alternative screening test may be comparatively better in subsets of patients. Thus, this pilot study aims to compare the currently used screening test for primary aldosteronism namely the plasma aldosterone renin ratio (measured in blood samples) with 24-hour urine aldosterone measurement undertaken in a routinely collected 24-hour urine sample which is undertaken to assess water and salt balance in specialist hypertension clinics. 24-hour urine aldosterone is a test normally undertaken as part of a confirmatory test called an oral salt loading test in hypertensive patients suspected of primary aldosteronism, however not at the screening stage. All procedures described in the study are part of the standard of care, with the only additional procedure being an assessment of 24-hour urine aldosterone in the routinely collected 24-hour urine electrolytes test.
Patients with clinical suspicion of primary aldosterone (typically patients with medication-resistant hypertension and/or hypertension with electrolyte disturbances) and patients without clinical suspicion will be recruited across 4 specialist hypertension centers in the UK over a period of 1 year. The results of this study will be used to plan and design a larger study and subsequently to compare the two tests in a wider population.REC name
Wales REC 6
REC reference
23/WA/0243
Date of REC Opinion
21 Aug 2023
REC opinion
Favourable Opinion