DARWIN EU® - Characterising the incidence and presentation of myocarditis and/or pericarditis in Europe

31/03/2026
31/03/2026
EU PAS number:
EUPAS1000000967
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000967

Study ID

1000000967

Official title and acronym

DARWIN EU® - Characterising the incidence and presentation of myocarditis and/or pericarditis in Europe

DARWIN EU® study

Yes

Study countries

Denmark
Finland
Germany
Netherlands
Norway
Spain
Sweden
United Kingdom

Study description

Myocarditis and pericarditis are rare but potentially serious conditions. Evidence on their incidence and presentation remains limited, with reported rates of acute myocarditis ranging from 6.3 to 8.6 per 100,000 individuals and pericarditis ranging from 3 to 32 cases per 100,000 individuals, with higher incidence observed among younger males and older adults. Overlap between myocarditis and pericarditis is frequently observed in clinical practice; Inflammatory myopericardial syndrome (IMPS) has been recently defined to describe the diverse spectrum of the potential overlap between these conditions.
More up-to-date estimates of myocarditis and/or pericarditis incidence and on their representation in terms of prodromes, diagnosis (imaging, biopsy, laboratory tests), management, and outcomes (hospitalisation and mortality) in European Real World Data (RWD) are needed to inform future potential vaccine or drug safety studies.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ivan Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable