Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis

NCT04264455 | Unknown FDA Device

• 1 other identifier: IT-II-2019
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations / arrhythmias / syncope, as well as (potentially) lethal clinical conditions in the sense of a cardiogenic shock or sudden cardiac death can be found. In 2015, the European Society of Cardiology (ESC) gave a IIa recommendation for the indication of an ICD vest restoration as "bridging" until the acute phase subsides (possibly normalisation of the left ventricular pump function with reduced probability of malignant cardiac arrhythmia) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability. The Monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis. The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients diagnosed with myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.

Conditions

Myocarditis Acute; Ventricular Arrythmia

Keywords

ICD; Life Vest; BioMonitor; Myocarditis; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (1)

• Monitoring the change of long-term incidence of ventricular arrhythmias in patients with acute myocarditis at several follow-up dates.

  The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias and/or sudden cardiac death in patients with diagnosed myocarditis and identify potential predictive factors for their occurrence. The 2-years incidence of sudden cardiac death and ventricular arrhythmias acquired by the respective device holters in use is investigated.

  24 months follow-up

Study Arms (3)

Biomonitor only

Patients receive a Biomonitor only

Device: Biomonitor; Device: Implantable Cardioverter-Defibrillator (ICD)

Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor

Patients receive a Wearable Cardioverter-Defibrillator (Life Vest) combined with a Biomonitor

Device: Biomonitor; Device: Life Vest; Device: Implantable Cardioverter-Defibrillator (ICD)

ICD Implantation

Patients receive an ICD only

Device: Implantable Cardioverter-Defibrillator (ICD)

Interventions

Biomonitor DEVICE

Patients receive a Biomonitor only

Biomonitor only; Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor

Life Vest DEVICE

Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally

Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor

Implantable Cardioverter-Defibrillator (ICD) DEVICE

Patients receive an Implantable Cardioverter-Defibrillator (ICD)

Biomonitor only; ICD Implantation; Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups will be selected from all patients attending the participating hospitals.

You may qualify if:

• secured myocarditis via MRT / endomyocardial biopsy
• ventricular arrhythmias (≥ 5 beats) in the ECG / LZ ECG with clinical indication for a WCD system/ biomonitor/ or the indication for primary/secondary prophylactic ICD implantation
• presence of informed consent
• age \>18 and \<85 years

You may not qualify if:

• Participation in another study with an active treatment group
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• MVZ Leopoldina GmbH: collaborator
• Brandenburg Medical School Theodor Fontane: collaborator
• Hannover Medical School: collaborator

Study Sites (1)

Wuerzburg University Hospital

Würzburg, Bavaria, 97080, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

hsTroponin T, CK, CK-MB, NT-proBNP, renal retention parameters, LDH, GOT, CRP, blood count, electrolytes

MeSH Terms

Conditions

Myocarditis

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Peter Nordbeck, MD, PhD

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

• Jonas Muentze, MD

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Moser

CONTACT

0049 (0) 931 201 39946; moser_c@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Peter Nordbeck

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: February 11, 2020
• Study Start: October 24, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

DE (1)