Study of Metyrapones Effect on Heart and Blood Pressure Health in Adults with Adrenal Nodules and Mild Cushings Syndrome

What this Trial Is About

Researchers are studying patients with bilateral adrenal incidentalomas linked to subclinical Cushings syndrome to evaluate the effects of Metirapone on cardiovascular risk factors. This controlled, randomized, open-label study is conducted across multiple centers and includes phases for run-in, randomization, and intervention. The goal is to understand how Metirapone may influence blood pressure management and related metabolic markers in these patients. The study has three phases. In the run-in phase, patients receive standardized antihypertensive therapy to stabilize blood pressure. Then, they are randomly assigned to either Metirapone plus antihypertensive therapy or antihypertensive therapy alone. Metirapone is given in capsules starting at 250 mg daily, with possible dose increases up to 750 mg daily, adjusted based on cortisol levels and side effects. Patients on Metirapone are monitored weekly for the first month for dose adjustments and safety. Blood pressure and metabolic parameters are regularly assessed throughout the intervention phase, which lasts up to 12 months. Participants will have regular medical visits for blood pressure checks, blood and saliva sample collections for steroid level monitoring, and heart and blood vessel assessments. Home blood pressure monitoring is also done before visits. The study measures changes in antihypertensive drug use, cardiovascular function, and adrenal gland changes. After the study, participants undergo further abdominal CT scans as part of routine care. The total study duration includes up to 10 months for run-in and 12 months of treatment, with close monitoring throughout.

Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome