Effects of adrenal incidentalomas on heart and metabolism
Official title: Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Run by University of Roma La Sapienza · NCT04127552 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | January 2, 2019 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | March 28, 2025 |
| Trial ID | NCT04127552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with incidentally detected adrenal masses and possible autonomous cortisol secretion.
✕Probably not a fit
Patients with overt Cushing's syndrome, pheochromocytoma, or other specified adrenal disorders will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated potential benefits of surgical intervention in similar patient populations, suggesting that this approach may be promising.
Who can join: the full rules
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 it's running
-
Department of Experimental Medicine
Rome, Italy, Italy Recruiting
Study contacts
- Principal investigator: Andrea M Isidori, MD, PHD — Sapienza
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.