Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Subclinical/Mild Cushing's Syndrome
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
∙ \- BP \>100/60 mmHg and \<130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.
Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Azienda Ospedale-Università Padova
RECRUITING
Padova
Contact Information
Primary
Guido Di Dalmazi, MD
guido.didalmazi@unibo.it
+390512143009
Time Frame
Start Date:2021-02-23
Estimated Completion Date:2025-02-17
Participants
Target number of participants:50
Treatments
Experimental: Group A
Metirapone in addition to standardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines. Metirapone will be provided in 250-mg capsules, in the form of commercially available packs. In Group A, patients will receive Metirapone at the initial dosage of 250 mg, 1 capsule per day. Dosage may be adjusted according to clinical response and tolerability, up to a maximum of 750 mg (3 capsules per day). The drug should be taken after a meal. The drug should be stored at room temperature. The expected duration of study treatment is 12 months, after which patients will discontinue Metirapone and continue with therapies as per the normal course of care.
Active_comparator: Group B
Standardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines.