HypertensionPURLNCT06047912
Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
An observational study of Hypertension and Primary Aldosteronism, run by Dr Ian B Wilkinson at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Primary Aldosteronism, Urine Aldosterone
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Vascular Research Clinic, Adenbrooke's Centre of Clinical Investigation, Addenbrooke's Hospital
Cambridge
Ian Wilkinson, DM, MRCP, 01223586852, cuh.purl@nhs.net
About this study
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.
Read the 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.
- Conditions
- Hypertension, Primary Aldosteronism, Urine Aldosterone
- Medical subject headings
- Hypertension, Hyperaldosteronism
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Degree of agreement between a positive/negative ARR and a positive/negative 24-hr urine aldosterone
Measured: 1 year
Secondary outcomes (2)
Number of patients who required oral salt loading
Measured: 1 year
The predictive value of a positive aldosterone renin ratio or 24-hr urine aldosterone with a positive confirmatory test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Ian B Wilkinson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ian Wilkinson, DM, MRCP, Study chair, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047912
- Sponsor's protocol ID
- A096651
- Acronym
- PURL
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
- ClinicalTrials.gov ID
- NCT06047912
- Acronym / sponsor ID
- PURL / A096651
- Conditions
- Hypertension, Primary Aldosteronism, Urine Aldosterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr Ian B WilkinsonUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- A patient will be eligible for inclusion in this trial only if all of the following criteria apply:
Key exclusion criteria (5 listed)
- • Severe hypertension (sustained blood pressure of >200/110 mmHg) or a history of known secondary hypertension other than PA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Wilkinson, DM, MRCP study chair
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Primary Aldosteronism, run by Dr Ian B Wilkinson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spoorthy Kulkarni, MD, MRCP (01223586865, cuh.purl@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.