Primary Aldosteronism
Conditions
Keywords
primary aldosteronism, metomidate, adrenal venous sampling
Brief summary
The goal of this randomised open-label controlled study is to compare the biochemical and clinical responses following \[11C\]Metomidate-PET CT(MTO-PET) versus usual care with adrenal venous sampling as first lateralisation strategy in people with biochemically confirmed primary aldosteronism(PA). The main question it aims to answer is: what is the proportion of people who achieved complete or partial clinical success among those who underwent PA treatment?
Interventions
PROCEDURE[11C] Metomidate PETCT
Metomidate labelled with C11H3(\[11C\]Metomidate) is used as a radiotracer in PET-CT to detect expression of CYP11B1 and CYP11B2 in adrenal cortex.
PROCEDUREAdrenal Venous Sampling
Adrenal venous sampling is an invasive procedure that involves insertion of a catheter to adrenal veins to determine if one side of the adrenal is producing excess aldosterone hormones compared to the other side.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PA made based on Endocrine Society guidelines: * Participants should demonstrate a positive screening test for primary aldosteronism, defined as: * Paired measurement of renin and aldosterone demonstrating a raised aldosterone-to-renin ratio \>550 pmol/L/ng/mL/h AND * Suppressed renin \<=1ng/ml/h * AND participants should demonstrate autonomous aldosterone secretion following salt-loading confirmatory tests, defined as: * 1\) Non-suppressed aldosterone \>162pmol/L following seated saline infusion OR * 2\) raised 24-hour urine aldosterone \>38 nmol/d following oral salt loading test (17) * For participants with spontaneous hypokalemia with renin below detection level and plasma aldosterone \> 416 pmol/L(by LC-MS) at screening, the above confirmatory tests can be omitted due to high pre-test probability as proposed by latest guidelines (10). * Adrenal nodule on CT
Exclusion criteria
* Unable to give informed consent * Participants who neither agree to AVS nor MTO-PET * Patients who indicate they will not proceed to adrenalectomy * Patients contraindicated for mineralocorticoid receptor antagonists * Patients who are unable/unwilling or contraindicated for dexamethasone required for MTO-PET * Estimated GFR \< 30 ml/min/1.73m2 * Any illness or condition that is considered unfit for study by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the proportion of people who achieved complete or partial clinical success | at 6 and 12 months | Clinical success is defined by Primary Aldosteronism Surgical Outcome criteria for people who underwent surgery and Primary Aldosteronism Medical Treatment Outcome criteria for those who received mineralocorticoid receptor antagonist |
Countries
Hong Kong
Contacts
CONTACTEdith WK Chow, MBChB
Outcome results
None listed