Clinical Trial: IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title:

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.

Detailed Summary:

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 (This is the conventional period of time for which spironolactone is withdrawn prior to AVS.)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 investiga
Sponsor: Queen Mary University of London

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• 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.
• 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.
• 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.
• 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.
• 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

Original Secondary Outcome: Same as current

Information By: Queen Mary University of London

Dates:
Date Received: September 5, 2016
Date Started: October 2016
Date Completion: October 2020
Last Updated: October 25, 2016
Last Verified: August 2016