Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adrenalectomy.
- Who it may be relevant to
- Registry conditions: Adrenal Incidentaloma, Hypercortisolism, Adrenal Tumor. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Overview
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.
Detailed description
Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.
Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.
Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.
Interventions
- Procedure Adrenalectomy
Adrenalectomy according to 2016 ESE guidelines
Primary outcome measures
- Echocardiographic Change of Left Ventricular Hypertrophy [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
Secondary outcome measures (12)
- Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation. [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation. [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in blood Coagulation Tests [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in Dual X-Ray Absorptiometry T-score [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Radiological evaluation of adrenal mass [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sleep disturbances using questionnaire (PSQI) [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Infectious diseases frequency and severity with modified German Diseases Questionnaire [Time frame: Baseline (T0), after 1 year (t1) and 5 years (t2)]
- Quality of life: SF-36-Item Health Survey questionnaire [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Psychometric Evaluation: Beck Depression Inventory questionnaire [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sexual dysfunction using FSFI questionnaire in woman [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sexual dysfunction using IIEF questionnaire in man [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in insulin resistance calculated with HOMA index [Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Department of Experimental Medicine — Rome
Publications
- De 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/ PMID 41572809
Identifiers
NCT: NCT04127552 · ITACA