Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

N/AActive Not RecruitingNCT04917757

Wuerzburg University Hospital3,656 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

3,656

Conditions

Adrenal Incidentaloma

Interventions

1mg Dexamethasone testDIAGNOSTIC_TEST

For each patient a 1mg dexamethasone test has been performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Würzburg

Würzburg, Germany

University Turin

Turin, Italy

Outcomes

Primary Outcomes

Mortality

death

Time frame: 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.

Secondary Outcomes

Cardiovascular Morbidity

Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)

Time frame: 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.

Data from ClinicalTrials.gov

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