Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

Active, not recruiting

• Conditions: Adrenal Incidentaloma

• Registration Number: NCT04917757
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

The primary aim of the study is to assess mortality and cardiovascular events potentially linked to cortisol excess in patients with adrenal incidentalomas stratified by cortisol values following the 1-mg overnight dexamethasone test.

Detailed Description

The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-08-31
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-08
• Results First Submitted: 2023-02-04
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3656

Inclusion Criteria

• age ≥18 years
• adrenal incidentaloma (≥ 1cm) detected by cross-sectional imaging between January 1, 1996 and December 31, 2015
• imaging characteristics suggestive for an adrenal adenoma or excluded malignancy by follow-up imaging
• availability of a 1 mg dexamethasone test result
• follow-up data on living status and occurrence of cardiovascular events
• follow-up duration of at least 36 months.

Exclusion Criteria

• proven pheochromocytoma, primary hyperaldosteronism or adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome
• clinical features suggestive for overt Cushing's syndrome; urinary free cortisol (UFC) ≥ 2-fold higher than the upper limit of normal of the local assay
• any active malignancy (including adrenocortical cancer) at the time of primary diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	From date of primary diagnosis of the adrenal incidentaloma to the date of death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.	death

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Morbidity	From date of primary diagnosis of the adrenal incidentaloma to the date of the first CV event or death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.	Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)

Trial Locations

Locations (2)

University Hospital Würzburg; 🇩🇪 Würzburg, Germany

University Turin; 🇮🇹 Turin, Italy