ARrhythmias in MYocarditis

NCT03801681 | Unknown

• 1 other identifier: ARMY
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Myocarditis promotes the occurrence of serious cardiac arrhythmias and conduction disorders which may lead to sudden cardiac death, the need for catheter ablation of arrhythmia or implantation of a cardioverter-defibrillator or pacemaker. The aim of the study is to fill the evidence gap regarding the type and burden of arrhythmias in patients with myocarditis and their correlation with clinical parameters, biomarkers and additional tests. During a multi-center observational study, patients will be subjected to prolonged ECG monitoring. As a result, a risk scale will be created that can facilitate the identification of patients with an increased risk of arrhythmia and further specifying recommendations for therapeutic management.

Conditions

Myocarditis; Heart Failure; Endomyocardial Biopsy; Arrythmia; Sudden Cardiac Death; Biomarker; Cardiomyopathy

Keywords

myocarditis; heart failure; endomyocardial biopsy; arrythmia; sudden cardiac death; biomarker; cardiomyopathy; high-sensitive troponin; galectin-3; st-2; NT-proBNP

Outcome Measures

Primary Outcomes (5)

• Assessment of type and burden of arrhythmia using Holter-ECG monitoring in patients with myocarditis.

  During the Holter-ECG monitoring type and burden of arrhythmias or cardiac rhythm disorders will be assessed.

  3 months

• Time to occurrence of new heart failure, heart failure hospitalizations or heart failure outpatient visits.

  it will be assessed on clinical interview during control visits

  1 year

• Time to occurrence of cardiovascular hospitalization.

  it will be assessed on clinical interview during control visits

  1 year

• Time to occurrence to left ventricular systolic dysfunction.

  left ventricular systolic dysfunction occurrence will be assessed using echocardiography during control visits.

  1 year

• Time to occurrence to left ventricular diastolic dysfunction.

  left ventricular diastolic dysfunction occurrence will be assessed using echocardiography during control visits.

  1 year

Secondary Outcomes (2)

• Correlation of serum biomarkers concentrations with cardiac remodeling

  1 year

• Correlation of serum biomarkers concentrations with inflammation

  1 year

Study Arms (1)

myocarditis

patients with clinically suspected myocarditis

Diagnostic Test: ECG holter monitoring

Interventions

ECG holter monitoring DIAGNOSTIC_TEST

patients will be monitored using ECG-holter

myocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients admitted to the hospital having clinically suspected myocarditis

You may qualify if:

• clinically suspected myocarditis
• age ≥ 18 years
• signed informed consent to participate in the study

You may not qualify if:

• previous history of heart failure
• already Implanted implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) or pacemaker (PM)
• history of percutaneous ablation due to arrhythmias
• history of arrhythmias or conduction disorders
• active cancer
• advanced chronic kidney disease
• chronic inflammatory disease
• previous or current myocardial infarction
• current myocardial ischemia as the cause of arrhythmia

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Chair and Department of Cardiology, Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Myocarditis; Heart Failure; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Cardiomyopathies

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Grzegorz Opolski, Professor

  Medical University of Warsaw

  STUDY CHAIR

• Krzysztof J Filipiak, Professor

  Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Krzysztof Ozierański, MD

CONTACT

22 5991958; krzysztof.ozieranski@gmail.com

Agata Tymińska, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 11, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: principal investigator approval

Locations

PL (1)