Effects of adrenal incidentalomas on heart and metabolism
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
This study looks at how having adrenal incidentalomas affects heart health and metabolism in patients, and whether surgery or watchful waiting is better for their overall health over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT04127552 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the cardiovascular and metabolic changes in patients with adrenal incidentalomas and possible autonomous cortisol secretion (pACS). It aims to determine the impact of surgical intervention, specifically adrenalectomy, versus conservative management on these health parameters over a five-year follow-up period. The study will assess patients with non-functioning adrenal adenomas, those receiving conservative treatment, and those undergoing surgery, comparing their outcomes to patients without adrenal masses. Data will be collected at baseline, one year, and five years post-intervention to evaluate the effectiveness of the treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with incidentally detected adrenal masses and possible autonomous cortisol secretion.
Not a fit: Patients with overt Cushing's syndrome, pheochromocytoma, or other specified adrenal disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with adrenal incidentalomas, potentially reducing cardiovascular and metabolic risks.
How similar studies have performed: Previous studies have indicated potential benefits of surgical intervention in similar patient populations, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Incidentally detected adrenal mass Exclusion Criteria: * Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage * Patients taking medications influencing glucocorticoid production or metabolism * Patients with psychiatric diseases or alcohol abuse * Pregnancy
Where this trial is running
Rome, Italy
- Department of Experimental Medicine — Rome, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea M Isidori, MD, PHD — Sapienza
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.