IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism (MATCH)
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ClinicalTrials.gov Identifier: NCT02945904 |
Recruitment Status : Unknown
Verified January 2018 by Queen Mary University of London.
Recruitment status was: Recruiting
First Posted : October 26, 2016
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment |
---|---|
Primary Aldosteronism Hyperaldosteronism | Procedure: adrenalectomy |

Study Type : | Observational |
Estimated Enrollment : | 165 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Actual Study Start Date : | October 2016 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | November 30, 2021 |

- Procedure: adrenalectomy
Unilateral adrenalectomy for Conn's adenoma
- Normalisation of aldosterone renin ratio (ARR) [ Time Frame: Baseline to 6 month Primary endpoint ]change in aldosterone- renin ratio for renin activity/renin mass
- Mean home systolic blood pressure [ Time Frame: Baseline to 6 month primary endpoint ]Changes in average home systolic blood pressures
- Biochemical success using PASO categorical criteria complete, partial or absent [ Time Frame: Baseline to 6 month Primary endpoint ]correction of hypokalaemia and normalisation of aldosterone-to- renin ratio
- Clinical success using PASO categorical criteria complete, partial or absent [ Time Frame: Baseline to 6 month Primary endpoint ]Reduction in blood pressure and reduction anti-hypertensive medication
- Normal range serum potassium levels [ Time Frame: Baseline to 6 month Primary endpoint ]normalisation of low serum potassium
- Change in Aldosterone - renin ratio renin activity/renin mass (ARR) [ Time Frame: Baseline to 6 month Primary endpoint ]change of ARR
- Change in home systolic and diastolic blood pressure [ Time Frame: Baseline to 6 month Primary endpoint ]change in home blood pressure readings
- Change in clinic systolic and diastolic blood pressures [ Time Frame: Baseline to 6 month Primary endpoint ]change in clinic blood pressures
- change in troponin, Brain naturetic pepetide [ Time Frame: Baseline to 6 month Primary endpoint ]serum measurements for troponin , naturetic Peptide
- change in cardiac MRI measurements [ Time Frame: Baseline to 6 month Primary endpoint ]Cardiac MRI scan at baseline and primary endpoint visit.
- Change in quality of life [ Time Frame: Baseline to 6 month Primary endpoint ]change in quality of life measures.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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
- 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, 2016)
- 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:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945904
Contact: Morris Brown, Prof | 2078823901 | morris.brown@qmul.ac.uk | |
Contact: Jackie Salsbury, nursing | j.salsbury@qmul.ac.uk |
United Kingdom | |
Queen Mary University of London | Recruiting |
City Of London, United Kingdom, EC1 6BQ | |
Contact: Morris Brown, Prof of Hypertension 2078823901 morris.brown@qmul.ac.uk | |
Contact: Jackie Salsbury, Nursing j.salsbury@qmul.ac.uk | |
Principal Investigator: William Blake, Professor Endocrinology |
Responsible Party: | Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT02945904 |
Other Study ID Numbers: |
011149 |
First Posted: | October 26, 2016 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Hyperaldosteronism Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases |