Active, not recruitingNCT04917757NAPACAUpdated Sep 5, 2025Results posted

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

An observational study in Adrenal Incidentaloma, sponsored by Wuerzburg University Hospital. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Wuerzburg University Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Other
Enrollment: 3,656
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

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

Conditions studied

Adrenal Incidentaloma

In context

Lead sponsor

Wuerzburg University Hospital is the lead sponsor of 96 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

patients with adrenal incidentaloma

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

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

Observational model: Cohort
Time perspective: Other
Enrollment: 3,656 participants (actual)
Target follow-up: 36 Months
Patient registry: Yes

Interventions

Diagnostic test1mg Dexamethasone test
For each patient a 1mg dexamethasone test has been performed.

What researchers measure

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.

Results

Posted Oct 8, 2024

Participant flow

Participant flow — Overall Study
Milestone	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion
Started	2089	1320	247
Completed	2089	1320	247
Not completed	0	0	0

Outcome measures

PrimaryMortality

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.
Reported as:: Count of participants · Participants

Mortality
Participants	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion
Mortality	143	168	41

SecondaryCardiovascular 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.
Reported as:: Count of participants · Participants

Cardiovascular Morbidity
Participants	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion
Cardiovascular Morbidity	145	130	22

Adverse events

Collected over From the date of primary diagnosis of the adrenal incidentaloma until the date of death or last follow-up (data lock December 31, 2018). Median follow-up duration was 7.0 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Non-functioning Adenoma	143/2,089 (6.8%)	145/1,892 (7.7%)	724/2,002 (36.2%)
Adenoma With Possible Autonomous Cortisol Secretion	168/1,320 (12.7%)	130/1,208 (10.8%)	547/1,250 (43.8%)
Adenoma With Autonomous Cortisol Secretion	41/247 (16.6%)	22/225 (9.8%)	123/232 (53%)

Most frequent serious events

Most frequent serious events
Event	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion
MACECardiac disorders	145/1892	130/1208	22/225

Most frequent other events

Most frequent other events
Event	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion
DylipidemiaMetabolism and nutrition disorders	724/2002	547/1250	123/232

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
<=18 years	0	0	0	0
Between 18 and 65 years	1404	726	134	2264
>=65 years	685	594	113	1392

Age, Continuous
Age, Continuous(years)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
Median	60 (52 to 67)	63 (52 to 67)	63 (55 to 70)	61 (53 to 68)

Sex: Female, Male
Sex: Female, Male(Participants)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
Female	1321	860	169	2350
Male	768	460	78	1306

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
Hispanic or Latino	34	28	5	67
Not Hispanic or Latino	2011	1271	238	3520
Unknown or Not Reported	44	21	4	69

Region of Enrollment
Region of Enrollment(participants)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
Europe	154	98	18	270
United States	1935	1222	229	3386

adenoma diameter
adenoma diameter(mm)	Non-functioning Adenoma	Adenoma With Possible Autonomous Cortisol Secretion	Adenoma With Autonomous Cortisol Secretion	Total
Median	20 (15 to 25)	26 (19 to 33)	29 (20 to 37)	22 (15 to 30)

Study locations

2 sites

University Hospital Würzburg
Würzburg, 97080, Germany
University Turin
Turin, Italy

References and documents

Publications

Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C, Concistre A, Ronchi CL, Altieri B, Mosconi C, Diamantopoulos A, Iniguez-Ariza NM, Vicennati V, Pia A, Kroiss M, Kaltsas G, Chrisoulidou A, Marina LV, Morelli V, Arlt W, Letizia C, Boscaro M, Stigliano A, Kastelan D, Tsagarakis S, Athimulam S, Pagotto U, Maeder U, Falhammar H, Newell-Price J, Terzolo M, Fassnacht M. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: an international, retrospective, cohort study. Lancet Diabetes Endocrinol. 2022 Jul;10(7):499-508. doi: 10.1016/S2213-8587(22)00100-0. Epub 2022 May 6. PubMed 35533704 ↗

Study documents

Protocol and statistical analysis plan · Oct 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — not yet decided.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04917757
Lead sponsor: Wuerzburg University Hospital
Collaborators: European Network for the Study of Adrenal Tumors
Responsible party: Martin Fassnacht (Chair Dept. of Endocrinology and Diabetes, Wuerzburg University Hospital) — Principal investigator
First posted: Jun 8, 2021
Start date: Jan 1, 2015
Primary completion: Aug 31, 2019
Completion: Dec 31, 2025 (estimated)
Results posted: Oct 8, 2024
Last update: Sep 5, 2025

Study contacts

Martin Fassnacht, MD

study chair · Wuerzburg University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Adrenal incidentaloma

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