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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 : Recruiting
First Posted : October 26, 2016
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
WBIC), Cambridge. University of Cambridge Addenbrookes Hospital, Cambridge CB2 2QQ
Robertson Centre for Biostatistics University of Glasgow Glasgow G12 8QQ
Barts and the London School of Medicine and Dentistry W Smithfield London - City of London EC1A 7BE
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:
Purpose of this clinical trial is to improve prediction of outcomes from surgical intervention in patients with Primary aldosteronism, and evaluate the merits of non-invasive metomidate PET CT versus adrenal vein sampling in the diagnosis of surgically correctable aldosteronism.

Condition or disease Intervention/treatment
Primary Aldosteronism Hyperaldosteronism Procedure: adrenalectomy

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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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: adrenalectomy
    Unilateral adrenalectomy for Conn's adenoma


Primary Outcome Measures :
  1. Normalisation of aldosterone renin ratio (ARR) [ Time Frame: Baseline to 6 month Primary endpoint ]
    change in aldosterone- renin ratio for renin activity/renin mass

  2. Mean home systolic blood pressure [ Time Frame: Baseline to 6 month primary endpoint ]
    Changes in average home systolic blood pressures


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Normal range serum potassium levels [ Time Frame: Baseline to 6 month Primary endpoint ]
    normalisation of low serum potassium

  4. Change in Aldosterone - renin ratio renin activity/renin mass (ARR) [ Time Frame: Baseline to 6 month Primary endpoint ]
    change of ARR

  5. Change in home systolic and diastolic blood pressure [ Time Frame: Baseline to 6 month Primary endpoint ]
    change in home blood pressure readings

  6. Change in clinic systolic and diastolic blood pressures [ Time Frame: Baseline to 6 month Primary endpoint ]
    change in clinic blood pressures

  7. change in troponin, Brain naturetic pepetide [ Time Frame: Baseline to 6 month Primary endpoint ]
    serum measurements for troponin , naturetic Peptide

  8. change in cardiac MRI measurements [ Time Frame: Baseline to 6 month Primary endpoint ]
    Cardiac MRI scan at baseline and primary endpoint visit.

  9. Change in quality of life [ Time Frame: Baseline to 6 month Primary endpoint ]
    change in quality of life measures.


Biospecimen Retention:   Samples With DNA
Following adrenalectomy tissue will be genotyped for somatic mutations in KCNJ5, ATP1A1, ATP2B3, CACNA1D, CTNNB1 and phenotyping by histological grading, gene expression and immunohistochemistry.


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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
Study Population
Patients diagnosed with primary aldosteronism
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

Information from the National Library of Medicine

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


Contacts
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Contact: Morris Brown, Prof 2078823901 morris.brown@qmul.ac.uk
Contact: Jackie Salsbury, nursing j.salsbury@qmul.ac.uk

Locations
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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         
Sponsors and Collaborators
Queen Mary University of London
National Institute for Health Research, United Kingdom
WBIC), Cambridge. University of Cambridge Addenbrookes Hospital, Cambridge CB2 2QQ
Robertson Centre for Biostatistics University of Glasgow Glasgow G12 8QQ
Barts and the London School of Medicine and Dentistry W Smithfield London - City of London EC1A 7BE
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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
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases