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

Recruiting now · Phase 4

Conditions studied: Adrenal Incidentalomas, Cushing Syndrome

In brief

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

Key facts

Study ID

NCT06801249

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

50

Starts

2021-02-23

Expected to finish

2025-02-17

Last updated by the study team

2025-01-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria - run-in (phase 1)
• 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.
• Inclusion criteria - randomization (phase 2)
• BP >100/60 mmHg and <130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.

You may not qualify if…

• 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.

Where it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (enrolling)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (enrolling)
• Azienda Ospedale-Università Padova — Padova, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.