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Effect of metyrapone on cardiovascular risk factors in patients with adrenal incidentalomas and subclinical/mild Cushing's syndrome
EU CTIS ID: 2024-518932-34-00
What this study is testing
The main aim of the study is to investigate the efficacy of adding Metyrapone to the standard antihypertensive treatment in improving blood pressure control of hypertensive patients with SCS and bilateral adrenal tumors
- Therapeutic use (Phase IV)
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
- Run-in Inclusion criteria for run-in phase: - age >18 years and <75 years - monolateral/bilateral nodules with benign radiological characteristics associated with enlarged adrenal limb width >5 mm at CT scan - SCS (absence of catabolic signs of Cushing’s syndrome) associated with at least one of the following conditions: o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and baseline ACTH <10 pg/mL o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and high salivary cortisol at 11 p.m. o Cortisol after 1 mg dexamethasone suppression test >138 nmol/L - Arterial hypertension (blood pressure =140/90 mmHg and/or current treatment with antihypertensive drugs) - Patients who are not candidate for adrenalectomy- Inclusion criteria-randomization (phase 2) - BP >100/60 mmHg and <130/85 mmHg undergoing antihypertensive therapy (lowest effective dose effective dose) within 6-10 months after enrollment-Written informed consent
You likely can't join if
- Body mass index =40 kg/m2 - Pregnancy or breastfeeding - Women in childbearing age who do not use barrier contraceptives. Barrier contraceptives are: o male or female condom with or without spermicide o cap, diaphragm or sponge with spermicide o a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) - Glucocorticoid treatment during the last year before enrollment - Drugs known to have interactions with Metyrapone - Drug allergy to Metyrapone or drugs belonging to the same class - Patients with severe illness - Patients with primary adrenal insufficiency and severe hypopituitarism - Patients with reduced liver function - Patients with untreated hypothyroidism or taking drugs acting on the hypothalamuspituitary-adrenal axis - Patients with drug hypersensitivity to Metyrapone or to one of the excipients listed in paragraph 6.1 of the summary of product characteristics (SPCs) – Metyrapone.
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.
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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.