CUSHMAH - Benefit of steroidogenesis inhibitors in Mild Cushing syndrome (Mild Autonomous Cortisol Secretion): a randomized trial in patients with Primary Bilateral Macronodular Adrenocortical Hyperplasia

Ki vehet részt

• Age ≥ 18 years old
• French speaking
• Patient with PBMAH as determined by adrenal imaging (CT-scan and/or MRI) showing multiples bilateral supracentrimetric adrenal nodules
• Mild autonomous cortisol secretion: plasma cortisol after 1 mg overnight dexamethasone test > 50 nmol/L, 24 h Urinary free cortisol < 1,5 upper limit of Normal
• Adrenal origin of cortisol excess: morning plasma ACTH < 10 pg/ml or between 10 and 20 pg/ml non responsive to CRH stimulation (stimulation < 50 %)
• Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or treated hypertension and/or diabetes that can be treated with antidiabetic treatments (WHO criteria)
• For women of childbearing potential (WOCBP), negative bHCG and highly effective contraception
• For male, an effective method of contraception
• Signed a written informed consent
• Affiliated to social security regime or an equivalent system

Ki nem vehet részt

• Steroidogenesis inhibitor treatment less than 6 weeks before inclusion
• Contraindication to steroidogenesis inhibitor
• Patients with a Cushing syndrome from another causes than PBMAH
• Patients with major psychiatric disorders that may interfere with the smooth running of the study
• Patients with proven primary adrenal insufficiency
• Hypersensitivity to the active substance or to one of its excipients
• Uncontrolled diabetes (HBA1c > 9 %)
• Patients at high risk of cardiac rhythm disorders with QT/QTc interval > 470ms (for women) and > 450ms (for men)
• Drugs with a known risk of QT prolongation as listed in https://crediblemeds.org
• Pregnancy or breastfeeding women
• Pathology that is life-threatening in the short term (1 year)
• Patients on AME (state medical aid)
• Participation to another clinical trial on medicinal products for human use
• Under glucocorticoid (systemic or high dose local) treatment
• Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia