Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations

NCT04127552 | Recruiting

• 1 other identifier: ITACA
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adrenal Incidentaloma; Hypercortisolism; Adrenal Tumor

Outcome Measures

Primary Outcomes (1)

• Echocardiographic Change of Left Ventricular Hypertrophy

  Change of Left Ventricular Hypertrophy will be evaluated by transthoracic echocardiography. Patients will be examined in the left lateral decubitus position according to the American Society of Echocardiography guidelines.

  at Baseline (T0) and after 1 year (t1) and 5 years (t2)

Secondary Outcomes (14)

• Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation.

  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.

  at Baseline (T0) and after 1 year (t1) and 5 years (t2)

• Change in blood Coagulation Tests

  at Baseline (T0) and after 1 year (t1) and 5 years (t2)

• Change in Dual X-Ray Absorptiometry T-score

  at Baseline (T0) and after 1 year (t1) and 5 years (t2)

• Radiological evaluation of adrenal mass

  at Baseline (T0) and after 1 year (t1) and 5 years (t2)

Study Arms (4)

Patients with non-functioning adrenal adenoma

Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L

Patients with pACS receiving conservative management

Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management

Patients with pACS receiving adrenalectomy

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

Procedure: Adrenalectomy

Healthy controls

Patients without adrenal masses

Interventions

Adrenalectomy PROCEDURE

Adrenalectomy according to 2016 ESE guidelines

Patients with pACS receiving adrenalectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)

You may qualify if:

• Incidentally detected adrenal mass

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Experimental Medicine

Rome, Italy, 00161, Italy

RECRUITING

Related Publications (1)

• 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 Jan 23:lvag018. doi: 10.1093/ejendo/lvag018. Online ahead of print.

  PMID: 41572809 DERIVED

MeSH Terms

Conditions

Adrenal incidentaloma; Cushing Syndrome; Adrenal Gland Neoplasms

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andrea M Isidori, MD, PHD

  Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Endocrinology

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 15, 2019
• Study Start: January 2, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)