Is metomidate PET-CT superior to adrenal venous sampling in predicting outcome from adrenalectomy in patients with primary hyperaldosteronism?

Not Applicable

Completed

Conditions: Primary aldosteronism
Nutritional, Metabolic, Endocrine
Primary hyperaldosteronism

Registration Number: ISRCTN91387205

Lead Sponsor: Queen Mary University of London

Brief Summary: 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36646800/ (added 13/02/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 143

Inclusion Criteria

1. Male or female age >18 years
2. Diagnosis of PHA based on published Endocrine Society consensus guidelines
3. Patients will be enrolled/consented when they have had each of the following:
3.1. At least one paired measurement of plasma renin and aldosterone, measured off spironolactone, showing an elevated ARR
3.2. Either a plasma aldosterone >190 pmol/L after saline infusion or ‘spontaneous hypokalemia + plasma renin below detection levels + plasma aldosterone > 550 pmol/L)’ (as per Endocrine Society guidance)
3.3. A CT or MRI scan of the adrenals with probable or definite adenoma(s)
4. Patients with elevated ARR can be put forward for consideration by the MDT as exceptional cases in whom spironolactone is not (fully) withdrawn, and/or saline suppression is not performed, IF:
4.1. 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
4.2. 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
5. All patients will have a positive Aldosterone renin ratio (ARR) serum measurement with another local diagnostic confirmatory test as specified from local specialised APA Guidelines. This is often standard cross-sectional imaging by CT or MR scanning. Any exception to recommended diagnostic criteria will be subject to approval by monthly MDT

Exclusion Criteria

1. 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
2. Patients contraindicated for spironolactone therapy
3. Any patients continuing on beta-blockers or direct renin blockers
4. Pregnant/breastfeeding females or women unable/unwilling to take secure contraceptive precautions whilst undergoing investigations
5. Patients unwilling/unable to take the dexamethasone required to prepare for a metomidate PET-CT scan
6. Any illness, condition or drug regimen that is considered a contraindication by the PI

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Aldosterone renin ratio in patients with primary aldosteronism (Conn's adenoma) is measured using serum aldosterone and renin ratio at baseline and 6 months after treatment <br>2. Home systolic blood pressure is measured using an automatic brachial blood pressure monitor at baseline and 6 months after treatment

Secondary Outcome Measures

Name	Time	Method
1. Number of patients achieving home systolic blood pressure <140mmHg on no treatment is measured by an automatic brachial blood pressure monitor at baseline and 6 months after treatment<br>2. Number of participants requiring less antihypertensive medication following treatment is measured using class and dosage of antihypertensive medications at baseline and 6 months after treatment<br>3. SUV max ratios between adenoma and normal adrenal are measured using 11-C Metomidate PET CT scan at baseline and 6 months after treatment<br>4. Reduction in home systolic blood pressure mmHg on 4-week spironolactone therapy is measured using an automatic brachial blood pressure monitor at baseline and 4 weeks<br>5. High sensitivity troponin serum level is measured using serum troponin levels at baseline and 6 months after treatment<br>6. Serum brain natriuretic peptide level is measured using serum brain natriuretic levels at baseline and 6 months after treatment

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