MyocarditisNCT05610423
Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
An observational study of Myocarditis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a national multicenter study in Norway investigating of individuals with Covid-19 vaccine associated myocarditis (VAM) and pericarditis in Norway. The main objective is to validate the reported possible cases of Covid-19 vaccine associated myo-and pericarditis in Norway as well as investigate for predisposing… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Myocarditis
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2022to 31 Dec 2032
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Covid-19 vaccine associated myocarditis and pericarditis
Who may be able to join
- Confirmed myocarditis (definite, probable, possible) by Brighton criteria < 90 days after either Covid-19 vaccine.
Who cannot join
- Other more likely cause of myocarditis, including Covid-19 infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a national multicenter study in Norway investigating of individuals with Covid-19 vaccine associated myocarditis (VAM) and pericarditis in Norway.
The main objective is to validate the reported possible cases of Covid-19 vaccine associated myo-and pericarditis in Norway as well as investigate for predisposing factors and risk factors for developing these vaccine adverse events.
Furthermore, patients with confirmed Covid-19 VAM, will be invited to participate in a prospective cohort study, investigating for cardiac long-term adverse effects 1 year and 2 years after vaccine-associated myocarditis.
Read the detailed description
Myocarditis and pericarditis following vaccination with Covid-19 vaccines has been reported as rare but unexpected and potentially severe vaccine adverse events.
In Norway, all vaccines administrated are registered in the national vaccine registry (SYSVAK). All in-hospital diagnoses are reported in a national diagnosis registry (NPR). These complete national high-quality registers allow linking diagnosis of myocarditis and pericarditis to vaccine data (date, product, dose number) on an individual level.
Oslo University Hospital, in collaboration with the Norwegian Institute of Public Health and the Norwegian Medicines Agency, will perform a study consisting of 2 parts:
Part 1 "Validation study":
Eligible patients for inclusion are all individuals with suspected / reported Covid - 19 vaccine associated pericarditis and myocarditis in Norway from 2021 and onwards. Patients will be identified by linking data from the Norwegian Patient registry NPR (ICD-10 diagnostic codes for pericarditis and myocarditis) and the Immunization registry (SYSVAK) (< 90 days since vaccination). The diagnosis of Covid-19 vaccine associated pericarditis and myocarditis will then be confirmed or rejected by medical record search according to international accepted Brighton criteria. The Brighton collaboration criteria provide evidence levels of diagnostic certainty of myocarditis and pericarditis based on cardiac signs and symptoms, cardiac enzymes, ECG findings, imaging studies and histopathology.The criteria is used to distinguish between suspected, probable and confirmed diagnosis of myocarditis and pericarditis. Patients with another more likely reason for confirmed myocarditis or pericarditis by Brighton will not be classified with Covid-19 vaccine associated myocarditis (VAM) or pericarditis, respectively.
Part 2 "Clinical follow-up study" All patients identified in the validation study with confirmed Covid-19 VAM will be invited to participate in the prospective clinical follow-up study (all age groups, both sexes, all geographical areas of Norway). Inclusion wil be by informed consent. Data collection, symptom reporting and cardiac examinations (clinical examination, ECG, 24 hours Holter ECG, echocardiography, cardiac magnetic resonance imaging) will be performed at 1 and 2 years after a diagnosis of Covid -19 VAM. Blood analyses will be performed and a blood sample stored in a biobank in consenting participants. Clinical endpoints will be collected at 1 and 2 years follow-up.
- Conditions
- Myocarditis
- Being tested
- no intervention
- Keywords
- Vaccine side effect, Long term cardiac follow up
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention. Observational study only
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 vaccine associated myocarditis | No intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of myocardial scar
Quantification of myocardial scar by cardiac magnetic resonance (CMR).
Measured: 1 year post myocarditis
Reduced myocardial function
Assessment of myocardial function by echocardiography and CMR
Measured: 1 year post myocarditis
Presence of supraventricular arrhythmias
Presence, frequency and type supraventricular arrhythmias detected on ECG and 24 hours Holter ECG recording
Measured: 1 year post myocarditis
Presence of ventricular arrhythmias
Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours Holter ECG
Measured: 1 year post myocarditis
Persisting cardiac symptoms.
Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue.
Measured: 2 years post myocarditis
All cause death
Register death by cause
Measured: 1 year post myocarditis
Secondary outcomes (6)
Presence of myocardial scar
Quantification of myocardial scar by cardiac magnetic resonance (CMR).
Measured: 2 years post myocarditis
Reduced myocardial function
Assessment of myocardial function by echocardiography and CMR
Measured: 2 years post myocarditis
Presence of supraventricular arrhythmias
Presence, frequency and type supraventricular arrhythmias detected on ECG and 24
Measured: 2 years post myocarditis
Presence of ventricular arrhythmias
Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours
Measured: 2 years post myocarditis
Persisting cardiac symptoms.
Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue.
Measured: 2 years post myocarditis
All cause death
Register death by cause
Measured: 2 years post myocarditis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (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 MyocarditisStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Norwegian Medicines Agency
- Responsible party
- Principal investigator, Nina Eide Hasselberg, Oslo University Hospital
- Investigators
- Nina E Hasselberg, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610423
- Sponsor's protocol ID
- 434476
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagen BS, Vlaisavljevic K, Oppedal LS, Endresen J, Mohn VS, Fladseth K, Lysaker TM, Ribe MP, Moller TF, Hole TL, Dahl J, Karlstad O, Gulseth HL, Olsen DB, Greve-Isdahl M, Watle SV, Estensen ME, Broch K, Haugaa KH, Hasselberg NE. Myocarditis after COVID-19 mRNA vaccination in Norway: a nationwide validation study. Open Heart. 2026 May 4;13(1):e004112. doi: 10.1136/openhrt-2026-004112.
PubMed 42082376
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
- ClinicalTrials.gov ID
- NCT05610423
- Acronym / sponsor ID
- 434476
- Conditions
- Myocarditis
- Keywords
- Vaccine side effect, Long term cardiac follow up
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Norwegian Medicines Agency
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 9 Nov 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.
This is a national multicenter study in Norway investigating of individuals with Covid-19 vaccine associated myocarditis (VAM) and pericarditis in Norway.
The main objective is to validate the reported possible cases of Covid-19 vaccine associated myo-and pericarditis in Norway as well as investigate for predisposing factors and risk factors for developing these vaccine adverse events.
Furthermore, patients with confirmed Covid-19 VAM, will be invited to participate in a prospective cohort study, investigating for cardiac long-term adverse effects 1 year and 2 years after vaccine-associated myocarditis.
Detailed description
Myocarditis and pericarditis following vaccination with Covid-19 vaccines has been reported as rare but unexpected and potentially severe vaccine adverse events.
In Norway, all vaccines administrated are registered in the national vaccine registry (SYSVAK). All in-hospital diagnoses are reported in a national diagnosis registry (NPR). These complete national high-quality registers allow linking diagnosis of myocarditis and pericarditis to vaccine data (date, product, dose number) on an individual level.
Oslo University Hospital, in collaboration with the Norwegian Institute of Public Health and the Norwegian Medicines Agency, will perform a study consisting of 2 parts:
Part 1 "Validation study":
Eligible patients for inclusion are all individuals with suspected / reported Covid - 19 vaccine associated pericarditis and myocarditis in Norway from 2021 and onwards. Patients will be identified by linking data from the Norwegian Patient registry NPR (ICD-10 diagnostic codes for pericarditis and myocarditis) and the Immunization registry (SYSVAK) (< 90 days since vaccination). The diagnosis of Covid-19 vaccine associated pericarditis and myocarditis will then be confirmed or rejected by medical record search according to international accepted Brighton criteria. The Brighton collaboration criteria provide evidence levels of diagnostic certainty of myocarditis and pericarditis based on cardiac signs and symptoms, cardiac enzymes, ECG findings, imaging studies and histopathology.The criteria is used to distinguish between suspected, probable and confirmed diagnosis of myocarditis and pericarditis. Patients with another more likely reason for confirmed myocarditis or pericarditis by Brighton will not be classified with Covid-19 vaccine associated myocarditis (VAM) or pericarditis, respectively.
Part 2 "Clinical follow-up study" All patients identified in the validation study with confirmed Covid-19 VAM will be invited to participate in the prospective clinical follow-up study (all age groups, both sexes, all geographical areas of Norway). Inclusion wil be by informed consent. Data collection, symptom reporting and cardiac examinations (clinical examination, ECG, 24 hours Holter ECG, echocardiography, cardiac magnetic resonance imaging) will be performed at 1 and 2 years after a diagnosis of Covid -19 VAM. Blood analyses will be performed and a blood sample stored in a biobank in consenting participants. Clinical endpoints will be collected at 1 and 2 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 vaccine associated myocarditis | – | Other: no interventionNo intervention |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Covid-19 vaccine associated myocarditis and pericarditis
Key inclusion criteria (1 listed)
- Confirmed myocarditis (definite, probable, possible) by Brighton criteria < 90 days after either Covid-19 vaccine.
Key exclusion criteria (1 listed)
- Other more likely cause of myocarditis, including Covid-19 infection.
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 |
|---|---|---|
| no interventionNo intervention. Observational study only | Other | Covid-19 vaccine associated myocarditis |
Primary outcome
Presence of myocardial scar
Time frame: 1 year post myocarditis
Quantification of myocardial scar by cardiac magnetic resonance (CMR).
Reduced myocardial function
Time frame: 1 year post myocarditis
Assessment of myocardial function by echocardiography and CMR
Presence of supraventricular arrhythmias
Time frame: 1 year post myocarditis
Presence, frequency and type supraventricular arrhythmias detected on ECG and 24 hours Holter ECG recording
Presence of ventricular arrhythmias
Time frame: 1 year post myocarditis
Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours Holter ECG
Persisting cardiac symptoms.
Time frame: 2 years post myocarditis
Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue.
All cause death
Time frame: 1 year post myocarditis
Register death by cause
6 secondary outcomes
Presence of myocardial scar
Time frame: 2 years post myocarditis
Reduced myocardial function
Time frame: 2 years post myocarditis
Presence of supraventricular arrhythmias
Time frame: 2 years post myocarditis
Presence of ventricular arrhythmias
Time frame: 2 years post myocarditis
Persisting cardiac symptoms.
Time frame: 2 years post myocarditis
All cause death
Time frame: 2 years post myocarditis
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 1 Aug 2023.
- Derived from this study: PubMed 42082376Hagen BS, Vlaisavljevic K, Oppedal LS, Endresen J, Mohn VS, Fladseth K, Lysaker TM, Ribe MP, Moller TF, Hole TL, Dahl J, Karlstad O, Gulseth HL, Olsen DB, Greve-Isdahl M, Watle SV, Estensen ME, Broch K, Haugaa KH, Hasselberg NE. Myocarditis after COVID-19 mRNA vaccination in Norway: a nationwide validation study. Open Heart. 2026 May 4;13(1):e004112. doi: 10.1136/openhrt-2026-004112.
- Individual participant dataSharing planned: No
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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.
Nina E Hasselberg, MD, PhD principal investigator
Oslo University 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 Myocarditis, run by Oslo University Hospital at 1 site in Norway.
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 1 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: enrolling by invitation, as of the sponsor's last update on 1 Aug 2023. 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 Norway. 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?
Presence of myocardial scar (time frame: 1 year post myocarditis). The study lists 6 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 NCT05610423, 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 1 Aug 2023.