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

NCT06047912 | Unknown

• 1 other identifier: A096651
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Primary Aldosteronism; Urine Aldosterone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Ian B Wilkinson: lead

Study Sites (1)

Vascular Research Clinic, Adenbrooke's Centre of Clinical Investigation, Addenbrooke's Hospital

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Ian Wilkinson, DM, MRCP

  University of Cambridge

  STUDY CHAIR

Central Study Contacts

Spoorthy Kulkarni, MD, MRCP

CONTACT

01223586865; cuh.purl@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)