NCT06801249 Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome
| NCT ID | NCT06801249 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Adrenal Incidentalomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-02-23 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2021-02-23 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
Eligibility Criteria
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.
Contact & Investigator
Guido Di Dalmazi, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06801249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Adrenal Incidentalomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06801249 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06801249 currently recruiting?
Yes, NCT06801249 is actively recruiting participants. Contact the research team at guido.didalmazi@unibo.it for enrollment information.
Where is the NCT06801249 trial being conducted?
This trial is being conducted at Bologna, Italy, Naples, Italy, Padova, Italy.
Who is sponsoring the NCT06801249 clinical trial?
NCT06801249 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Guido Di Dalmazi, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 50 participants.