Impact of Metyrapone on Heart Health in Patients with Adrenal Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the effects of Metyrapone on cardiovascular risk factors in patients with bilateral adrenal incidentalomas and subclinical Cushing's syndrome. It involves a controlled, randomized, open-label design across three phases: a run-in phase with standardized antihypertensive therapy, followed by randomization and an interventional phase. Patients will undergo regular monitoring of blood pressure and cardiovascular health indicators throughout the study. The aim is to assess how Metyrapone influences blood pressure and other cardiovascular metrics in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Guido Di Dalmazi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Guido Di Dalmazi, MD
• Email: guido.didalmazi@unibo.it
• Phone: +390512143009

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.