An observational study in Myocarditis, Heart Failure and Myocardial Fibrosis, sponsored by Johann Wolfgang Goethe University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Johann Wolfgang Goethe University Hospital · Observational
Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).
Participants are consecutive asymptomatic healthy subjects or patients from subgroups with known high risk (such as a recent COVID19 infection) with no known or clinically relevant cardiac disease or currently prescribed cardiac medication.
Exclusion Criteria:
Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography, blood sampling and cardiopulmonary exercise testing.
All-cause mortality
number of deaths
Time frame: 1 year
All-cause mortality
number of deaths
Time frame: 5 years
Heart Failure Outcome
Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure
Time frame: 1 year and 5 years
Cardiovascular Outcome
Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)
Time frame: 1 year and 5 years
Arrhythmia Outcome
Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT
Time frame: 1 year and 5 years
Plan to share: No
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Johann Wolfgang Goethe University Hospital