Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms >5 mm on abdominal CT scan
Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with baseline ACTH <10 pg/mL
Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with increased nocturnal (11 pm) salivary cortisol
Cortisol levels after dexamethasone 1 mg test >138 nmol/L
Body mass index ≥40 kg/m2
Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay
Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom with or without spermicide o Cervical cup, diaphragm or sponges with spermicide o Combination of male condom and cervical cup, diaphragm or sponges with spermicide (dual barrier methods)
Treatment with steroids in the last year before enrollment
Parallel
Metarapone
DrugMetirapone is an inhibitor of the enzyme 11-β-adrenal hydroxylase, which is deputed to catalyze the conversion of 11-desoxycortisol (11-S) to cortisol and 11-deoxycorticosterone (DOC) to corticosterone.
Standardized antihypertensive therapy
DrugStandardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines.
Change in Number and/or Dosage of Antihypertensive Drugs at 12 Months with Metirapone Treatment, Maintaining Target Blood Pressure Range
This measure will assess any change in the number or dosage of antihypertensive medications required after 12 months of treatment with Metirapone, while maintaining the target blood pressure range (BP \>100/60 mmHg and \<130/85 mmHg).
"Concentration of Key Biomarkers in Plasma for Monitoring Efficacy of Metirapone Therapy
This outcome measure evaluates the efficacy of Metirapone therapy by quantifying the concentration of specific biomarkers in plasma. Each biomarker will be measured at predefined time points during the study to monitor changes over time and assess therapeutic response. The values for each biomarker will be reported separately to ensure clarity in units of measure and clinical significance.
"Assessment of Changes in Adrenal Gland Morphology Following Metirapone Therapy
This outcome measure evaluates morphological changes in the adrenal glands after treatment with Metirapone. Changes will be summarized as mean differences in adrenal gland size and percentage of participants showing notable structural changes.
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