Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis

Not Applicable

Completed

• Conditions: Myocarditis Viral
• Interventions: Diagnostic Test: endomyocardial biopsy

• Registration Number: NCT04312490
• Lead Sponsor: Assiut University

Brief Summary

Viral myocarditis has been recognized as a cause of congestive heart failure, however diagnosis and treatment represents a challenging process. Recently, there is an increasing frequency of different cardiotropic viruses in the clinical setting of myocarditis. The introduction of the new molecular techniques in analysing the etiologic agent of acute myocarditis has enhanced significantly the knowledge on the molecular epidemiology of these viruses. The etiology of patients admitted to our university hospital remains unclear. It is therefore important to identify the aetiology associated with myocardial infections.

The purpose of the present study is to analyze the prevalence of a broad spectrum of cardiotropic viruses, including enteroviruses, adenoviruses and parvo B19 virus, in adults with suspected myocarditis with special reference to B19 virus due to its increasing prevalence nowadays.

The results of this study will provide a very important information for the prevalent infectious viral agents in our university hospital which will guide treatment protocol.

Detailed Description

Objectives

1. There are almost no data regarding the relative prevalence of viral pathogens associated with myocarditis and the demographic and clinical features related to these infections in Egypt. Therefore, our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool.

2. Our second aim is to determine the distribution of mono- and coinfections between these viral agents.

3. Finally, to correlate between the microbiological findings in this study and patient characteristics including age, sex, clinical features, regional distribution, and degree of urbanization (determined on the basis of the size of the city and the density of the population) of the patients.

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-18
• Primary Completion: 2021-10-01
• Status Verified: 2021-11
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• all patients with recent unexplained heart failure in last 3 months and diagnosed as myocarditis by cardiac magnetic resonance (CMR) after exclusion of ischemic (by coronary angio) or valvular (by detailed ECHO) causes.

Exclusion Criteria

• ischemic cardiomyopathy.
• peripartum cardiomyopathy
• valvular etiology of heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	endomyocardial biopsy	all patients with myocarditis

Primary Outcome Measures

Name	Time	Method
prevalence of the most common viruses	12 months	our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool.

Secondary Outcome Measures

Name	Time	Method
Determine the distribution of mono- and co-infections between these viral agents.	12 months	Using PCR techniques to detect if single infection or multiple viral infection per pateint

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt