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 study about?

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.

1 enrollment and initial assessment

Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes verifying age between 18 and 75 years, and the presence of adrenal nodules with specific characteristics.

Participants will be evaluated for subclinical or mild Cushing’s syndrome, which involves specific cortisol levels after a dexamethasone suppression test and other criteria related to blood pressure and adrenal health.

2 run-in phase

During this phase, participants will continue their current antihypertensive treatment. Blood pressure will be monitored to ensure it remains within a specific range.

This phase lasts between 6 to 10 months, during which the effectiveness of the current treatment is assessed.

3 randomization and treatment

Participants who meet the criteria will be randomly assigned to receive the study medication, metyrapone, in addition to their standard antihypertensive treatment.

The medication, Cormeto 250 mg capsule molli, is taken orally. The dosage and frequency will be determined by the study team based on individual needs.

4 treatment duration

The treatment with metyrapone will continue for 12 months. During this time, regular check-ups will be conducted to monitor blood pressure and adjust medication as needed.

The primary goal is to reduce the number or dose of antihypertensive drugs while maintaining blood pressure within the target range.

5 end of study

At the end of the 12-month treatment period, a final assessment will be conducted to evaluate the effects of the treatment on cardiovascular risk factors.

Participants will receive a summary of their health status and any changes in their treatment plan will be discussed.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country	Status
Azienda Ospedaliera di Padova	Padua	Italy
Aelwyzl Ucpes Schsanlbu Lghyoi Dz Boyltwl	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	22.09.2020

Trial locations

Investigated drugs:

Metyrapone

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.

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 ID:

2024-518932-34-00

Protocol code:

GR-MET-19

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Metyrapone on Heart Health in Patients with Adrenal Tumors and Mild Cushing’s Syndrome

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