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IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outc... | Recruiting
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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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Medical Conditions
  • Primary Aldosteronism
  • Hyperaldosteronism
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02945904
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • This is an observational cohort study which takes place within existing secondary and tertiary care practice of the NHS. It is a multi-centre study in which all participants to have the same two investigations performed in random order. These are as follows:

    11C- metomidate PET CT This is a one-hour non-invasive study, prior to which participants are treated with dexamethasone for 3 days.

    Adrenal Vein Sampling This is an invasive investigation in which both adrenal veins are cannulated and blood collected for measurement of adrenal steroid hormones. Adrenocorticotrophic hormone (ACTH) is administered prior to AVS in order to ensure steroid hormone secretion during the procedure.

    The investigators will standardise the start-time of treatment with spironolactone, which is first-choice treatment for participants with primary aldosteronism, in order that the pre-spironolactone blood pressure and biochemistry can be compared with subsequent measurements post-surgery, and the changes during the first month of spironolactone treatment can be used to assess their value in predicting response to surgery.

    Sub-study of Repeat Metomidate PET CT before and after Spironolactone therapy

    In order to determine whether it will be necessary for the start of spironolactone treatment to be delayed in all participants until after both investigations are completed, the investigators will perform a sub-study, early in MATCH, in which 6 patients have their PET CT repeated after at least 6 weeks treatment with spironolactone. (This is the conventional period of time for which spironolactone is withdrawn prior to AVS.)

    Follow-up management and investigations The investigators anticipate ~50% of participants will be found on one or both investigations to have unilateral PA, and be recommended for adrenalectomy.

    The primary outcome measurements will be at 6 months after surgery.

    Primary outcomes:

    1. Change in ARR from baseline to 6 months after treatment

    2. Change in SBP (mean of at least 18 measurements from 3 days' home monitoring), from baseline to 6 months after treatment

    Secondary outcomes

    1. Cure of hypertension, defined as the proportion of patients in whom average home blood Pressure measurements 6 months post adrenalectomy are <140/90 mmHg on no treatment.

    2. Prediction of cure of hypertension, by one or more of:

    1. The ratio of SUVmax between tumour and normal adrenal;

    2. Blood pressure fall on spironolactone (50 mg daily for 2 weeks, 100 mg daily for 2 weeks), measured as the difference in home systolic blood pressure

    3. Post-operative analyses of the APA, to include genotyping for somatic mutations in KCNJ5, CACNA1D, ATP1A1, ATP2B3, CTNNB1 and phenotyping by histological grading (zona fasciculata versus zona glomerulosa), gene expression and immunohistochemistry.

    3. Change in home blood pressure from baseline at follow-up visits other than 6 months post-adrenalectomy.

    4. Reduction in number of antihypertensive drugs

    5. Change from baseline in blood levels of Troponin, Brain Natriuretic Peptide. The judgement as to which patients have met primary and secondary outcomes will be made by a critical endpoints committee meeting every 3-6 months throughout the study.

    The sample size calculation has been performed to permit detection of a significant influence on outcome where the smallest number of patients will be available. This is the group of patients in whom the two diagnostic techniques give discordant results, estimated to be ~20% of the total. Recruitment of 140 patients across 3 centres over 3 years (<1/centre/month), with an estimated 70 proceeding to adrenalectomy, permits 90% power at alpha=0.01 of detecting superiority of PET CT over AVS.
Phase
Sorry, this information is not available
Study Design
Sorry, this information is not available
Study Type
Observational
Intervention
Procedure : adrenalectomy
Intervention Type
See Interventions above
Primary Outcome Measures
    Aldosterone renin ratio changes in patients with primary aldosteronism (Conn's adenoma) from baseline to 6 months after treatment.; Baseline to 6month post treatment; Home systolic blood pressure in mmHg change from baseline to 6 months after treatment.; baseline to 6month post treatment
Secondary Outcome Measures
    Number of patients achieving Home systolic blood pressure <140mmHg on no treatment 6 months post treatment.; baseline to 6 months post treatment; Number of Participants requiring less numbers of antihypertensive medication following treatment.; Baseline to 6 months post treatment; SUV max ratios between adenoma and normal adrenal; Baseline to 6 months post treatment; Reduction in home systolic blood pressure mmHg on 4 week spironolactone therapy; baseline to 4 weeks; High sensitivity Troponin serum level changes from baseline to post 6 month post treatment; Baseline to 6month post treatment; Serum Brain natriuretic Peptide level changes from baseline to 6 month post treatment.; Base line to 6 month post treatment
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
140
Participant Inclusion Criteria
    Inclusion Criteria:

    - Male or female: Age >18 yrs.

    - Diagnosis of PHA based on published Endocrine Society consensus guidelines.

    - Patients will be enrolled/consented when they have had each of the following:

    1. At least one paired measurement of plasma renin and aldosterone, measured off spironolactone, showing an elevated ARR.

    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. a CT or MRI scan of the adrenals with probable or definite adenoma(s)

    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:

    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

    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:

    - 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 therapy.

    - Any patients continuing on beta-blockers or direct renin blockers .

    - Pregnant / breastfeeding females or women 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.

    - Any illness, condition or drug regimen that is considered a contraindication by the PI
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
City Of London
EC1 6BQ
Trial Contact(s)
Primary Trial Contact
Morris Brown, Prof
2078823901
Other Trial Contacts
Jackie Salsbury, nursing
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Sorry, this information is not available
EudraCT Number
Not available for this trial
Funder(s)
  • 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
Other Study ID Numbers
011149
Sponsor(s)
Queen Mary University of London
Key Dates

Recruitment Start Date

Oct 2016

Recruitment End Date

Oct 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 Sep 2016

Date updated in source

05 Mar 2018