Clinical trial NCT04312490: Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
Official title: Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocarditis Viral
Keywords: VIRAL MYOCARDITIS
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Science and Technology Development Fund (STDF)
First posted: 2020-03-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of the most common viruses
timeFrame: 12 months
Secondary outcomes:
measure: Determine the distribution of mono- and co-infections between these viral agents.
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
References:
citation: Hassan AKM, Fouad DA, Refaiy A. Demographic features and prevalence of myocarditis in patients undergoing transarterial endomyocardial biopsy for unexplained cardiomyopathy. Egypt Heart J. 2017 Mar;69(1):29-35. doi: 10.1016/j.ehj.2016.09.005. Epub 2016 Oct 10.
citation: Khidr SS, El-Mokhtar MA, Asaad SR, Hetta HF, Abdel-Rahim MH, Youssef AAA, Hassan AKM. Clinical course, viral etiology, and the diagnostic workup for patients with suspected myocarditis: a single-center prospective study. BMC Cardiovasc Disord. 2022 Sep 6;22(1):396. doi: 10.1186/s12872-022-02833-0.