Actively Recruiting
Effect of Metirapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Subclinical/Mild Cushing's Syndrome
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-30
50
Participants Needed
3
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with bilateral adrenal incidentalomas linked to subclinical Cushing's syndrome to evaluate the effects of Metirapone on cardiovascular risk factors. This controlled, randomized, open-label study is conducted across multiple centers and includes phases for run-in, randomization, and intervention. The goal is to understand how Metirapone may influence blood pressure management and related metabolic markers in these patients. The study has three phases. In the run-in phase, patients receive standardized antihypertensive therapy to stabilize blood pressure. Then, they are randomly assigned to either Metirapone plus antihypertensive therapy or antihypertensive therapy alone. Metirapone is given in capsules starting at 250 mg daily, with possible dose increases up to 750 mg daily, adjusted based on cortisol levels and side effects. Patients on Metirapone are monitored weekly for the first month for dose adjustments and safety. Blood pressure and metabolic parameters are regularly assessed throughout the intervention phase, which lasts up to 12 months. Participants will have regular medical visits for blood pressure checks, blood and saliva sample collections for steroid level monitoring, and heart and blood vessel assessments. Home blood pressure monitoring is also done before visits. The study measures changes in antihypertensive drug use, cardiovascular function, and adrenal gland changes. After the study, participants undergo further abdominal CT scans as part of routine care. The total study duration includes up to 10 months for run-in and 12 months of treatment, with close monitoring throughout.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Unilateral or bilateral adrenal nodules with benign features and adrenal arm thickening >5 mm on abdominal CT scan
- Subclinical Cushing's syndrome confirmed twice in 6 months by specified cortisol and ACTH levels
- Hypertension (blood pressure ≥140/90 mmHg or on antihypertensive medication)
- Patients who cannot undergo surgery
- Blood pressure between >100/60 mmHg and <130/85 mmHg on lowest effective antihypertensive dose within 6-10 months after enrollment
- Signed informed consent
You will not qualify if you...
- Body mass index ≥40 kg/m2
- Pregnant or breastfeeding women
- Women of childbearing age not using approved barrier contraceptive methods
- Steroid treatment in the last year before enrollment
- Use of medications interfering with Metirapone
- Known or suspected allergy to Metirapone or related drugs
- Serious medical conditions contraindicating study participation
- Primary adrenal insufficiency, impaired adrenal secretion, or severe hypopituitarism
- Impaired liver function
- Untreated hypothyroidism or treatment affecting hypothalamic-pituitary-adrenal axis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monthly visits for up to 10 months to stabilize blood pressure with antihypertensive therapy
Duration - Minimum 2 months to maximum 10 months
Participants receive standardized antihypertensive therapy to stabilize blood pressure before randomization.
Monthly visits for blood pressure evaluation and medication adjustment
Duration - Up to 12 months
Participants are randomized to receive either Metirapone plus antihypertensive therapy or antihypertensive therapy alone. Metirapone dosing is titrated with close monitoring during the first month and possibly extended up to 4 months to reach the maximum tolerated dose.
Weekly visits for the first month (or longer if dose titration continues), then every 4 weeks thereafter
Duration - Up to 6 months after treatment completion
Participants undergo cardiovascular and metabolic evaluations at the end of treatment, and abdominal CT scans are repeated within 6 months after study completion as part of routine care.
Visits scheduled as part of routine clinical care, including one abdominal CT scan
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
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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