Recurrent Acute Myocarditis Registry

• Conditions: Cardiomyopathy; Myocarditis

• Registration Number: NCT04589156
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-08-31
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-14
• Last Update Submitted: 2020-10-14
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained ventricular arrhythmia	0 - 1 year after last acute myocarditis episode	Any ventricular arrhythmia (VT/VF) : * sustained (lasting more than 30 seconds); * symptomatic or not (including sudden cardiac arrest); * induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)
Genetic mutation	0 - 1 year after last acute myocarditis episode	Any genetic mutation (cardiomyopathy panel)

Secondary Outcome Measures

Name	Time	Method
Myocardial substrate characterization	0 - 1 year after last acute myocarditis episode	Cardiac magnetic resonance imaging (left and right ventricular ejection fractions, volumes, late gadolinium enhancement)
Nonsustained ventricular arrhythmia	0 - 1 year after last acute myocarditis episode	Any ventricular arrhythmia (VT/VF) : * nonsustained (lasting less than 30 seconds); * symptomatic or not; * induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Normandy, France