Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Recruiting
Study on the Effect of Metyrapone on Heart Health in Patients with Adrenal Tumors and Mild Cushing's Syndrome
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of the medication metyrapone on certain health conditions. The diseases being studied are adrenal incidentalomas and subclinical/mild Cushing's syndrome. Adrenal incidentalomas are unexpected tumors found in the adrenal glands, which are located above the kidneys. Subclinical/mild Cushing's syndrome is a condition where the body produces too much of the hormone cortisol, but without the obvious symptoms of Cushing's syndrome. The medication being tested, metyrapone, is taken in the form of a soft capsule.
The purpose of this study is to see if adding metyrapone to the usual treatment for high blood pressure can help improve blood pressure control in patients who have both high blood pressure and the conditions mentioned above. Participants in the study will take metyrapone along with their regular blood pressure medication. The study will last for about 12 months, during which the effects of metyrapone on blood pressure and the need for blood pressure medications will be monitored.
The main goal is to find out if metyrapone can reduce the number or dose of blood pressure medications needed while keeping blood pressure within a healthy range. This study aims to provide more information on how metyrapone can be used to help manage blood pressure in patients with adrenal incidentalomas and subclinical/mild Cushing's syndrome.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- Age between 18 and 75 years old.
- Presence of one or two nodules (small lumps) in the adrenal glands, which appear non-cancerous on a CT scan, with an adrenal limb width greater than 5 mm.
- Have Subclinical Cushing's Syndrome (SCS), which means having some hormone imbalances without obvious symptoms of Cushing's syndrome. This includes at least one of the following:
- Cortisol level after a 1 mg dexamethasone suppression test is greater than 50 nmol/L and baseline ACTH (a hormone) is less than 10 pg/mL.
- Cortisol level after a 1 mg dexamethasone suppression test is greater than 50 nmol/L and high salivary cortisol at 11 p.m.
- Cortisol level after a 1 mg dexamethasone suppression test is greater than 138 nmol/L.
- Have arterial hypertension, which means blood pressure is equal to or higher than 140/90 mmHg, or currently taking medication to lower blood pressure.
- Not a candidate for adrenalectomy, which is a surgery to remove one or both adrenal glands.
- For the second phase of the study, blood pressure should be greater than 100/60 mmHg and less than 130/85 mmHg while on the lowest effective dose of blood pressure medication for 6-10 months after joining the study.
- Provide written informed consent, which means agreeing to participate in the study after understanding all the details.
Who cannot join the trial?
5 criteria
- Patients who do not have adrenal incidentalomas (unexpected tumors found on the adrenal glands) and subclinical/mild Cushing's syndrome (a condition where the body produces too much cortisol, a stress hormone, but with mild or no obvious symptoms).
- Patients who are not within the specified age range for the study.
- Patients who are not part of the specified clinical trial groups.
- Patients who are not male or female, as both genders are included in the study.
- Patients who are not considered part of a vulnerable population, which may include groups like children, pregnant women, or those unable to consent.
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Investigated drugs
Metyrapone is a medication used in this clinical trial to help manage blood pressure in patients who have a condition called subclinical or mild Cushing's syndrome, along with adrenal tumors. This medication works by reducing the production of certain hormones in the body that can affect blood pressure. By adding Metyrapone to the usual treatment for high blood pressure, the study aims to see if it can help improve blood pressure control in these patients.
What is already known about the treatment
Metyrapone – Metyrapone is administered orally in the form of tablets. It is currently being studied for its potential benefits in patients with adrenal incidentalomas and subclinical or mild Cushing's syndrome, particularly in improving blood pressure control when added to standard antihypertensive treatment. The medication works by inhibiting an enzyme involved in cortisol production, thereby reducing cortisol levels in the body. Metyrapone is classified as an adrenal steroid synthesis inhibitor and is primarily used to manage conditions related to excessive cortisol production.
Investigated diseases
Adrenal Incidentalomas
Adrenal incidentalomas are unexpected tumors found in the adrenal glands, usually discovered during imaging tests for other conditions. These tumors are often non-functioning, meaning they do not produce hormones. However, some may secrete hormones, leading to various symptoms. The progression of adrenal incidentalomas can vary; some remain stable in size, while others may grow. Hormone-secreting tumors can lead to conditions like Cushing's syndrome or primary aldosteronism. Regular monitoring is often required to assess changes in size or hormone production.
Subclinical Cushing's Syndrome
Subclinical Cushing's syndrome is a condition where the adrenal glands produce slightly higher levels of cortisol without obvious symptoms of Cushing's syndrome. It is often detected incidentally during evaluations for other health issues. The condition can lead to subtle changes in metabolism, blood pressure, and bone density. Over time, these changes may increase the risk of developing metabolic disorders, hypertension, or osteoporosis. The progression is typically slow, and symptoms may remain mild or become more pronounced. Regular monitoring is essential to manage potential complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518932-34-00Protocol codeGR-MET-19Estimated enrolment50 patientsSponsorAzienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
sourced from the EU Clinical Trials Register and site verification
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