Clinical trial · Observational
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
NCT04127552CI-TRIAL-00087803ITACArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Incidentaloma | — | UNRESOLVED | — |
| Adrenal Tumor | Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Hypercortisolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adrenalectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Patients with non-functioning adrenal adenoma
- description
- Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L
- label
- Patients with pACS receiving conservative management
- description
- Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management
- label
- Patients with pACS receiving adrenalectomy
- description
- Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines
- interventionNames
- Procedure: Adrenalectomy
- label
- Healthy controls
- description
- Patients without adrenal masses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDe Alcubierre D, Ferrari D, Tomaselli A, Moscucci F, Bonaventura I, Francia A, Vozza E, Lospinuso I, Ettorre E, Hasenmajer V, Minnetti M, Sbardella E, Tenuta M, Morelli S, Paganini AM, Isidori AM, Pofi R. Long-term cardiac effects of adrenalectomy versus surveillance in mild cortisol excess: 5-year results from the prospective ITACA study. Eur J Endocrinol. 2026 Feb 4;194(2):170-184. doi: 10.1093/ejendo/lvag018. PMID 41572809