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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 24, 2025

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ClinConnect Summary

This clinical trial is studying the effects of a medication called Metyrapone on heart health in patients with adrenal incidentalomas and Cushing's syndrome. Adrenal incidentalomas are benign growths on the adrenal glands that may affect hormone levels, and Cushing's syndrome occurs when the body has too much cortisol, a hormone that helps control stress and metabolism. The trial is looking to see if Metyrapone can help reduce cardiovascular risks in these patients.

To be eligible for the study, participants should be between the ages of 27 and 74 and have certain conditions, such as having adrenal nodules that are not cancerous and experiencing signs of Cushing's syndrome without severe symptoms. Participants should also have high blood pressure that is being treated but not so high that it can't be controlled. Those who join the study will receive Metyrapone and be monitored over time to see how their heart health changes. It's important to know that certain individuals, such as those with severe obesity, pregnant women, or those taking other medications that might interfere with Metyrapone, cannot participate. The trial is currently recruiting participants, so if you or someone you know fits the criteria and is interested, it may be a good opportunity to contribute to important research.

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ALL

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.