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NCT Number: NCT04917757

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Adrenal Incidentaloma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Würzburg, Würzburg, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1mg Dexamethasone test

Diagnostic Test

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

Primary outcomes

  1. Mortality

    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.

    death

Secondary outcomes

  1. Cardiovascular Morbidity

    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.

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

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • European Network for the Study of Adrenal Tumors

Registry information

Official study title

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry

Acronym: NAPACA

Important dates

Study start
2015
Primary completion
2019
Study completion
2025
First posted
Jun 8, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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