Clinical trial Recruiting at 1 site Observational Ages 18 to 80

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.

More Hypercortisolism trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment68 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Rome, Italy)
StatusRecruiting
StartedJanuary 2, 2019
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedMarch 28, 2025
Trial IDNCT04127552 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.