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CUSHMAH - Benefit of steroidogenesis inhibitors in Mild Cushing syndrome (Mild Autonomous Cortisol Secretion): a randomized trial in patients with Primary Bilateral Macronodular Adrenocortical Hyperplasia
EU CTIS ID: 2023-507010-27-00
What this study is testing
Demonstrate that cortisol secretion inhibition by medical treatment (metyrapone) in PBMAH patients with MACS lead to improvement of hypertension and diabetes.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Patients with a Cushing syndrome from another causes than PBMAH
- Pregnancy or breastfeeding women
- Steroidogenesis inhibitor treatment less than 6 weeks before inclusion
- Pathology that is life-threatening in the short term (1 year)
- Patients with major psychiatric disorders that may interfere with the smooth running of the study
- Patients on AME (state medical aid)
See the full eligibility criteria
- 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
- Patients with a Cushing syndrome from another causes than PBMAH
- Pregnancy or breastfeeding women
- Steroidogenesis inhibitor treatment less than 6 weeks before inclusion
- Pathology that is life-threatening in the short term (1 year)
- Patients with major psychiatric disorders that may interfere with the smooth running of the study
- Patients on AME (state medical aid)
- Participation to another clinical trial on medicinal products for human use
- Patients with proven primary adrenal insufficiency
- Under glucocorticoid (systemic or high dose local) treatment
- Contraindication to steroidogenesis inhibitor
- Hypersensitivity to the active substance or to one of its excipients
- Uncontrolled diabetes (HBA1c > 9 %)
- Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.