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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Primary Aldosteronism; Urine Aldosterone

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Spoorthy Kulkarni, MD, MRCP; Phone Number: 01223586865; Email: cuh.purl@nhs.net

Study Locations

• United Kingdom
  • Cambridge, United Kingdom
    • Recruiting
    • Vascular Research Clinic, Adenbrooke's Centre of Clinical Investigation, Addenbrooke's Hospital
    • Contact: Ian Wilkinson, DM, MRCP; Phone Number: 01223586852; Email: cuh.purl@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Degree of agreement between a positive/negative ARR and a positive/negative 24-hr urine aldosterone	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients who required oral salt loading	1 year
The predictive value of a positive aldosterone renin ratio or 24-hr urine aldosterone with a positive confirmatory test	1 year

Collaborators and Investigators

• Sponsor: Dr Ian B Wilkinson
• Investigators: Study Chair: Ian Wilkinson, DM, MRCP, University of Cambridge

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hypertension; Hyperaldosteronism
• Other Study ID Numbers: A096651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No