Clinical trial NCT04589156: Recurrent Acute Myocarditis Registry
Official title: Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocarditis
Cardiomyopathy
Keywords: Recurrent acute myocarditis
Myocardial inflammation
Arrhythmogenic cardiomyopathy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent acute myocarditis.

Brief summary: The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

Detailed description: Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

Eligibility criteria: Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

Primary outcomes:
measure: Sustained ventricular arrhythmia
timeFrame: 0 - 1 year after last acute myocarditis episode
measure: Genetic mutation
timeFrame: 0 - 1 year after last acute myocarditis episode
Secondary outcomes:
measure: Myocardial substrate characterization
timeFrame: 0 - 1 year after last acute myocarditis episode
measure: Nonsustained ventricular arrhythmia
timeFrame: 0 - 1 year after last acute myocarditis episode
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
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