RecruitingPhase 4NCT06801249

Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome

"Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Subclinical/Mild Cushing's Syndrome

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

50 participants

Start Date

Feb 23, 2021

Study Type

INTERVENTIONAL

Conditions

Cushing Syndrome Adrenal Incidentalomas

Summary

Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms >5 mm on abdominal CT scan
SCS (detected 2 times in the 6 months before run-in) defined by the absence of catabolic signs of Cushing's syndrome in association with any of these 3 conditions:
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
Hypertension (BP ≥140/90 mmHg and/or ongoing antihypertensive treatment)
Patients who cannot undergo surgery
Acquisition of informed consent.
\- BP >100/60 mmHg and <130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.

Exclusion Criteria11

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
Taking medications known to interfere with Metirapone
Known or suspected hypersensitivity to the drug or drug class under study
Patients with serious clinical conditions that, in the opinion of the Investigator, contraindicate the patient's participation in the study
Patients with primary corticosurrenal insufficiency, impaired adrenal secretion, and severe hypopituitarism
Patients with impaired liver function
Patients with untreated hypothyroidism or being treated with drugs that have an action on the hypothalamic-pituitary-adrenal axis
Patients with hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 of the RCP - Metirapone.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMetarapone

Metirapone 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.

DRUGStandardized antihypertensive therapy

Standardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines.