Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 17 for:    Aldosterone-producing adenoma

IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism (MATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02945904
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : March 6, 2018
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

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Aldosterone renin ratio changes in patients with primary aldosteronism (Conn's adenoma) from baseline to 6 months after treatment. [ Time Frame: Baseline to 6month post treatment ]
    Changes in aldosterone/renin ratio in participants with primary aldosteronism Conn's adenoma, recommended for surgery or continued medical management following diagnostic testing with 11C- metomidate PET-CT and adrenal venous sampling.

  2. Home systolic blood pressure in mmHg change from baseline to 6 months after treatment. [ Time Frame: baseline to 6month post treatment ]
    Changes in home systolic blood pressures in participants with primary aldosteronism (Conn's adenoma) recommended for surgery or continued medical management following diagnostic testing with 11C- metomidate PET-CT and adrenal venous sampling.


Secondary Outcome Measures :
  1. Number of patients achieving Home systolic blood pressure <140mmHg on no treatment 6 months post treatment. [ Time Frame: baseline to 6 months post treatment ]
    Change in home blood pressure from baseline at follow-up visits 6 months post-adrenalectomy

  2. Number of Participants requiring less numbers of antihypertensive medication following treatment. [ Time Frame: Baseline to 6 months post treatment ]
    Participants requiring less medication from baseline amounts.

  3. SUV max ratios between adenoma and normal adrenal [ Time Frame: Baseline to 6 months post treatment ]
    Prediction of Cure of hypertension by changes in SUVmax between adenoma and normal adrenal.

  4. Reduction in home systolic blood pressure mmHg on 4 week spironolactone therapy [ Time Frame: baseline to 4 weeks ]
    Prediction of cure of hypertension by changes in home systolic blood pressure (mmHg) following 4 weeks of spironolactone therapy.

  5. High sensitivity Troponin serum level changes from baseline to post 6 month post treatment [ Time Frame: Baseline to 6month post treatment ]
    Prediction of cure of hypertension by changes in baseline High sensitivity serum troponin to 6 month post treatment.

  6. Serum Brain natriuretic Peptide level changes from baseline to 6 month post treatment. [ Time Frame: Base line to 6 month post treatment ]
    Prediction of cure of hypertension by changes in baseline serum Brain natriuretic peptide and following treatment at 6months


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 caused by a unilateral Conn's adenoma
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

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
Layout table for location contacts
Contact: Morris Brown, Prof 2078823901 morris.brown@qmul.ac.uk
Contact: Jackie Salsbury, nursing j.salsbury@qmul.ac.uk

Locations
Layout table for location information
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

Layout table for additonal information
Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02945904     History of Changes
Other Study ID Numbers: 011149
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases