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ARrhythmias in MYocarditis (ARMY)

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ClinicalTrials.gov Identifier: NCT03801681
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Krzysztof Ozieranski, Medical University of Warsaw

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.

Condition or disease Intervention/treatment
Myocarditis Heart Failure Endomyocardial Biopsy Arrythmia Sudden Cardiac Death Biomarker Cardiomyopathy Diagnostic Test: ECG holter monitoring

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Risk Assessment of Cardiac ARrhythmias in Patients With MYocarditis
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
myocarditis
patients with clinically suspected myocarditis
Diagnostic Test: ECG holter monitoring
patients will be monitored using ECG-holter




Primary Outcome Measures :
  1. Assessment of type and burden of arrhythmia using Holter-ECG monitoring in patients with myocarditis. [ Time Frame: 3 months ]
    During the Holter-ECG monitoring type and burden of arrhythmias or cardiac rhythm disorders will be assessed.

  2. Time to occurrence of new heart failure, heart failure hospitalizations or heart failure outpatient visits. [ Time Frame: 1 year ]
    it will be assessed on clinical interview during control visits

  3. Time to occurrence of cardiovascular hospitalization. [ Time Frame: 1 year ]
    it will be assessed on clinical interview during control visits

  4. Time to occurrence to left ventricular systolic dysfunction. [ Time Frame: 1 year ]
    left ventricular systolic dysfunction occurrence will be assessed using echocardiography during control visits.

  5. Time to occurrence to left ventricular diastolic dysfunction. [ Time Frame: 1 year ]
    left ventricular diastolic dysfunction occurrence will be assessed using echocardiography during control visits.


Secondary Outcome Measures :
  1. Correlation of serum biomarkers concentrations with cardiac remodeling [ Time Frame: 1 year ]
  2. Correlation of serum biomarkers concentrations with inflammation [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients admitted to the hospital having clinically suspected myocarditis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801681


Contacts
Contact: Krzysztof Ozierański, MD 22 5991958 ext +48 krzysztof.ozieranski@gmail.com
Contact: Agata Tymińska, MD

Locations
Poland
1st Chair and Department of Cardiology, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Krzysztof Ozierański, MD       krzysztof.ozieranski@gmail.com   
Principal Investigator: Krzysztof Ozierański, MD         
Sub-Investigator: Agata Tymińska, MD         
Sub-Investigator: Jerzy Kłoszewski, MD         
Sub-Investigator: Maciej Kusztal, MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Study Chair: Grzegorz Opolski, Professor Medical University of Warsaw
Study Chair: Krzysztof J Filipiak, Professor Medical University of Warsaw

Responsible Party: Krzysztof Ozieranski, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03801681     History of Changes
Other Study ID Numbers: ARMY
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after contact
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Access Criteria: principal investigator approval

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Krzysztof Ozieranski, Medical University of Warsaw:
myocarditis
heart failure
endomyocardial biopsy
arrythmia
sudden cardiac death
biomarker
cardiomyopathy
high-sensitive troponin
galectin-3
st-2
NT-proBNP

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Death
Death, Sudden, Cardiac
Myocarditis
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden