Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02945904
Eligibility Criteria:
Summary of eligibility criteria Inclusion Criteria
* Male or female: Age \>18 yrs.
* Diagnosis of PHA based on current published Endocrine Society consensus guidelines (Funder et al 2016)
Patients will be enrolled/consented when they have had each of the following:
At least one paired measurement of plasma renin and aldosterone, measured off spironolactone/eplerenone, showing an elevated ARR. With
1. either a plasma aldosterone \>190 pmol/L after saline infusion
2. or 'spontaneous hypokalemia + plasma renin below detection levels + plasma aldosterone \> 550 pmol/L)' (as per Endocrine Society guidance, 2016)
3. or failure to suppress plasma aldosterone by 30% + persistent PRA suppression after oral administration of captopril (as per Endocrine Society guidance, 2016)
and a CT or MRI scan of the adrenals with probable or definite adenoma(s) within the last five years
Patients with elevated ARR can be put forward for consideration by the MDT as exceptional cases in whom spironolactone/eplerenone is not (fully) withdrawn, and/or saline suppression is not performed, IF:
1. Plasma Aldosterone \> 450 pmol/L AND plasma renin \<0.5 pmol/ml/hr (\<9 mU/L) if measured on treatment with ACEI (Lisinopril \>=20 mg or equivalent) or ARB (Losartan 100 mg or equivalent); OR
2. Age \<40 AND definite adrenal adenoma on CT or MRI Patients whose CT/MRI does not show probable or definite adenoma must also be reviewed by MDT before enrolment/consent
Any exception to the above diagnostic criteria will be subject to approval by monthly MDT.
Exclusion Criteria
* Those patients who indicate that they are unlikely to proceed with surgery will not be recruited, because there will be no outcome change in blood pressure, restoration of normal renin/angiotensin physiology) against which to compare the accuracy of the two Investigations.
* Patients contraindicated for spironolactone or eplerenone therapy.
* Any patients continuing on beta-blockers or direct renin blockers .
* Patients with eGFR \<30 ml/min/ or expected to have a reduction in eGFR\<30ml/min on aldosterone antagonist therapy.
* Pregnant / breastfeeding females unable/unwilling to take secure contraceptive precautions whilst undergoing investigations.
* Patients unwilling/unable to take the dexamethasone required to prepare for a metomidate PET-CT scan.
* Patients unwilling to have both 11- C Metomidate PET CT scan and Adrenal Vein Sampling.
* Any illness, condition or drug regimen that is considered a contraindication by the PI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02945904
Study Brief:
Protocol Section:
NCT02945904