Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone

Hypertension Clinical Trial

— PURL  

Official title:

Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047912
• Other study ID #: A096651
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Spoorthy Kulkarni, MD, MRCP
• Phone: 01223586865
• Email: cuh.purl[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A patient will be eligible for inclusion in this trial only if all of the following

criteria apply:

• Aged 18 years and above.
• Meets NICE criteria for a diagnosis of hypertension with an age of onset of hypertension between 18-60 years.
• For cohort 2 (suspected primary aldosteronism): resistant hypertension, and/or hypertension with spontaneous or diuretic-induced hypokalaemia, and/or hypertension.

Exclusion Criteria:

• • Severe hypertension (sustained blood pressure of >200/110 mmHg) or a history of known secondary hypertension other than PA.
• Contraindications to confirmatory testing with saline infusion or oral salt loading test as per standard clinical criteria such as known clinical diagnosis of heart failure, and/or chronic kidney disease stage 3b.
• Known Pregnancy or breast feeding.
• Lack of informed consent.
• Any medical condition deemed unsuitable by investigator for participation in the study

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Locations

Country	Name	City	State
United Kingdom	Vascular Research Clinic, Adenbrooke's Centre of Clinical Investigation, Addenbrooke's Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Dr Ian B Wilkinson

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year
Primary	Degree of agreement between a positive/negative ARR and a positive/negative 24-hr urine aldosterone		1 year
Secondary	Number of patients who required oral salt loading		1 year
Secondary	The predictive value of a positive aldosterone renin ratio or 24-hr urine aldosterone with a positive confirmatory test		1 year