Primary AldosteronismSuddenDeathNCT05446779
Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death
An observational study of Primary Aldosteronism and Adrenal Cushing Syndrome, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Primary Aldosteronism, Adrenal Cushing Syndrome, Pheochromocytoma
- What is being tested?
- Adrenal aldosterone synthase (CYP11B2) staining, Adrenal cortisol synthase (CYP11B1) staining and Histopathological analysis
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- 3 Feb 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.
Who may be able to join
- Consecutive patients with out-of-hospital, sudden death
Who cannot join
- 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)
- Terminal disease
- Institutionalized patients
Trial locations and contacts
1 site in 1 country.
Finland1 site
Endocrinology, Helsinki University Hospital and University of Helsinki
Helsinki
About this study
Official title: Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)
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.
- Being tested
- Adrenal aldosterone synthase (CYP11B2) staining, Adrenal cortisol synthase (CYP11B1) staining, Histopathological analysis
- Medical subject headings
- Hyperaldosteronism, ACTH Syndrome, Ectopic, Pheochromocytoma, Endocrine Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenal aldosterone synthase (CYP11B2) stainingDiagnostic test
Immunoshistochemical diagnosis of primary aldosteronism
Adrenal cortisol synthase (CYP11B1) stainingDiagnostic test
Immunoshistochemical diagnosis of adrenal hypercortisolism
Histopathological analysisDiagnostic test
Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining; Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining; Diagnostic Test: Histopathological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP11B2 staining in adrenal glands
Histopathological diagnosis of the autopsy
Measured: Through study completion, an average of 2 years
CYP11B1 staining in adrenal glands
Histopathological diagnosis of the autopsy
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
CYP11B2 staining in adrenal glands
Histopathological diagnosis of the autopsy
Measured: Through study completion, an average of 2 years
Pheochromocytoma or paraganglioma
Histopathological diagnosis of the autopsy
Measured: Through study completion, an average of 2 years
Neuroendocrine tumor
Histopathological diagnosis of the autopsy
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start3 Feb 2022
- Primary completion31 Jan 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, University of Helsinki, Tampere University Hospital, Tampere University
- Responsible party
- Principal investigator, Niina Matikainen, Helsinki University Central Hospital
- Investigators
- Niina Matikainen, MD, PhD, Assoc Prof, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446779
- Sponsor's protocol ID
- THL/5008/5.05.00/2021
- Acronym
- SuddenDeath
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ylanen A, Isojarvi J, Virtanen A, Leijon H, Vesterinen T, Aro AL, Huhtala H, Kokko E, Porsti I, Viukari M, Nevalainen PI, Matikainen N. Adrenal aldosterone synthase (CYP11B2) histopathology and its association with disease-induced sudden death: a cross-sectional study. Lancet Reg Health Eur. 2025 Feb 6;51:101226. doi: 10.1016/j.lanepe.2025.101226. eCollection 2025 Apr.
PubMed 39995489
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)
- ClinicalTrials.gov ID
- NCT05446779
- Acronym / sponsor ID
- SuddenDeath / THL/5008/5.05.00/2021
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, University of Helsinki, Tampere University Hospital, Tampere University
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden death | – | Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining, Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining, Diagnostic Test: Histopathological analysisUnexpected 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 |
| Control | – | Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining, Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining, Diagnostic Test: Histopathological analysisDeath because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.
Key inclusion criteria (1 listed)
- Consecutive patients with out-of-hospital, sudden death
Key exclusion criteria (3 listed)
- 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)
- Terminal disease
- Institutionalized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenal aldosterone synthase (CYP11B2) stainingImmunoshistochemical diagnosis of primary aldosteronism | Diagnostic test | Control, Sudden death |
| Adrenal cortisol synthase (CYP11B1) stainingImmunoshistochemical diagnosis of adrenal hypercortisolism | Diagnostic test | Control, Sudden death |
| Histopathological analysisDiagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism | Diagnostic test | Control, Sudden death |
Primary outcome
CYP11B2 staining in adrenal glands
Time frame: Through study completion, an average of 2 years
Histopathological diagnosis of the autopsy
CYP11B1 staining in adrenal glands
Time frame: Through study completion, an average of 2 years
Histopathological diagnosis of the autopsy
3 secondary outcomes
CYP11B2 staining in adrenal glands
Time frame: Through study completion, an average of 2 years
Pheochromocytoma or paraganglioma
Time frame: Through study completion, an average of 2 years
Neuroendocrine tumor
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39995489Ylanen A, Isojarvi J, Virtanen A, Leijon H, Vesterinen T, Aro AL, Huhtala H, Kokko E, Porsti I, Viukari M, Nevalainen PI, Matikainen N. Adrenal aldosterone synthase (CYP11B2) histopathology and its association with disease-induced sudden death: a cross-sectional study. Lancet Reg Health Eur. 2025 Feb 6;51:101226. doi: 10.1016/j.lanepe.2025.101226. eCollection 2025 Apr.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niina Matikainen, MD, PhD, Assoc Prof principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Adrenal Cushing Syndrome, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CYP11B2 staining in adrenal glands (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.