Diagnosing Variable Primary Aldosteronism.

Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism; High Blood Pressure

Detailed Description

The main questions it aims to answer are:

• Can we diagnose more people if we used 24 hour urine measurements?
• In those with high amounts of aldosterone in their urine, is there a variable pattern to their aldosterone production?

Participants will have a 24 hour urine measurement. They will also have multiple blood tests throughout the day to study the variability in aldosterone secretion.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yun Ni Lee; Phone Number: +442078827275; Email: y.n.lee@qmul.ac.uk
• Study Contact Backup: Name: Tumi Kaminskas; Phone Number: +442078827275; Email: research.governance@qmul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Queen Mary University of London
    • Contact: Yun Ni Lee; Email: y.n.lee@qmul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with hypertension.

Description

Inclusion Criteria:

• People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity <0.5 nmol/h/L or renin mass <5 ng/L), plasma sodium > 140mmol/L or plasma potassium < 4mmol/L.
• Patients who have been diagnosed with PA and had previous aldosterone samples <277 pmol/L, a level which would normally not qualify for confirmatory testing.
• Patients with aldosterone results done at different times that indicate variability in production.
• Willing to consent and participate in the study.

Exclusion Criteria:

• Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
• People on end of life treatment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.	Can measurement of 24 hour urine tetrahydroaldosterone excretion detect more people with PA than current conventional screening tests?	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in timed day and night urine THA measurements.	We will be measuring the 24 hour urine THA samples in two separate (approximately 12 hours each) collections, one in the day and one at night. We can then study if there are any differences between day time and night time secretion which may help us understand the diurnal variation in aldosterone secretion.	12 months
Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.	This will allow us to study further if the reason why their screening blood test did not meet the threshold for diagnosis.	12 months
Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy	Complete clinical cure is daytime home or ambulatory BP < 135/<85mmHg, on no treatment. Partial clinical cure is BP < 135/<85 mmHg on the same or fewer drugs, not including a K+-sparing diuretic.	12 months
Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.	This is defined as (whilst off medications that might alter serum potassium or the RAS) by both: normalization of serum potassium and normalization of ARR or; elevated ARR and either baseline PAC <190pmol/L, or normal confirmatory test (saline infusion test or captopril challenge test).	12 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: William Drake, Prof, Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Anticipated): February 24, 2026
• Study Completion (Anticipated): February 24, 2026

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: February 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: 318689

Drug and device information, study documents

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