Actively Recruiting
Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-30
50
Participants Needed
3
Research Sites
207 weeks
Total Duration
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AI-Summary
What this Trial Is About
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
CONDITIONS
Official Title
Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral or bilateral adrenal nodules with benign features and adrenal arm thickening over 5 mm on abdominal CT scan
- Subclinical Cushing's syndrome confirmed twice in the last 6 months by specific cortisol and ACTH test results
- Hypertension defined as blood pressure 60/90 mmHg or ongoing antihypertensive treatment
- Patients who are not eligible for surgery
- Signed informed consent
- Blood pressure between 100/60 mmHg and 130/85 mmHg on the lowest effective antihypertensive therapy dose within 6-10 months after enrollment
You will not qualify if you...
- Body mass index 40 kg/m2 or higher
- Pregnant or lactating women
- Women of childbearing age not using barrier contraception methods
- Steroid treatment in the last year before enrollment
- Use of medications that interfere with Metirapone
- Known or suspected allergy to Metirapone or related drugs
- Serious clinical conditions that contraindicate study participation
- Primary adrenal insufficiency, impaired adrenal secretion, or severe hypopituitarism
- Impaired liver function
- Untreated hypothyroidism or treatment affecting the hypothalamic-pituitary-adrenal axis
- Hypersensitivity to Metirapone or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
2
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
3
Azienda Ospedale-Università Padova
Padova, Italy, 35128
Actively Recruiting
Research Team
G
Guido Di Dalmazi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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