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Clinical Trials in Italy / NCT06801249
Recruiting Phase 4

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

NCT06801249 · tracked via the Priya Life Science Italy tracker
Phase
Phase 4
Started
2021-02-23
Last updated
2025-01-30

Condition(s) studied

Adrenal IncidentalomasCushing Syndrome

Investigational drug(s) / intervention(s)

MetaraponeStandardized antihypertensive therapy

Metarapone: 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.

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Azienda Ospedaliera Universitaria Federico II Naples Italy Recruiting
Azienda Ospedale-Università Padova Padova Italy Recruiting

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801249 on ClinicalTrials.gov ↗ ← All trials in Italy