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Active, not recruitingNCT05446779SuddenDeathUpdated Apr 16, 2024

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

An observational study in Primary Aldosteronism, Adrenal Cushing Syndrome and Pheochromocytoma, sponsored by Helsinki University Central Hospital. Active, not recruiting at 1 site in Finland. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
400
Ages
35 Years to 70 Years
Sex
All
01

Study summary

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

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Conditions studied

  • Primary Aldosteronism
  • Adrenal Cushing Syndrome
  • Pheochromocytoma
  • Endocrine Neoplasia
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 103 observational studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

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

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Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Consecutive patients with out-of-hospital, sudden death

Exclusion criteria

Exclusion Criteria:

  1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown)
  2. Terminal disease
  3. Institutionalized patients
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sudden death

    Unexpected witnessed death occurring within an hour of the onset of symptoms in a person with or without previously known cardiac disease without an extra-cardiac cause, or unexpected unwitnessed death without extra-cardiac cause occurring in the previous 24 hours

    Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining · Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining · Diagnostic Test: Histopathological analysis

  • Control

    Death because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death

    Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining · Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining · Diagnostic Test: Histopathological analysis

Interventions

  • Diagnostic testAdrenal aldosterone synthase (CYP11B2) staining

    Immunoshistochemical diagnosis of primary aldosteronism

  • Diagnostic testAdrenal cortisol synthase (CYP11B1) staining

    Immunoshistochemical diagnosis of adrenal hypercortisolism

  • Diagnostic testHistopathological analysis

    Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

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What researchers measure

Primary outcomes

  1. CYP11B2 staining in adrenal glands

    Histopathological diagnosis of the autopsy

    Time frame: Through study completion, an average of 2 years

  2. CYP11B1 staining in adrenal glands

    Histopathological diagnosis of the autopsy

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. CYP11B2 staining in adrenal glands

    Histopathological diagnosis of the autopsy

    Time frame: Through study completion, an average of 2 years

  2. Pheochromocytoma or paraganglioma

    Histopathological diagnosis of the autopsy

    Time frame: Through study completion, an average of 2 years

  3. Neuroendocrine tumor

    Histopathological diagnosis of the autopsy

    Time frame: Through study completion, an average of 2 years

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Study locations

1 site
  • Endocrinology, Helsinki University Hospital and University of Helsinki
    Helsinki, Finland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Jan 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2022
First posted
Jul 7, 2022
StartActual
Feb 3, 2022
Primary completionActual
Jan 31, 2023
CompletionEst.
Dec 31, 2026
Last update
Apr 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05446779
Collaborators
Finnish Institute for Health and Welfare, University of Helsinki, Tampere University Hospital, Tampere University
Responsible party
Niina Matikainen (M.D., Ph.D, , Assoc. Prof., Helsinki University Central Hospital) — Principal investigator
First posted
Jul 7, 2022
Start date
Feb 3, 2022
Primary completion
Jan 31, 2023
Completion
Dec 31, 2026 (estimated)
Last update
Apr 16, 2024

Study contacts

Niina Matikainen, MD, PhD, Assoc Prof
principal investigator · Helsinki University Central 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 Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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