Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis (AIM-ICD)

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Arrythmia; Myocarditis Acute
• Intervention / Treatment: Device: Biomonitor; Device: Implantable Cardioverter-Defibrillator (ICD); Device: Life Vest

Detailed Description

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. In the first phase of acute myocarditis direct cell damage, in a second phase myocardial inflammation with additional myocardial damage can be observed. Symptoms vary widely and may include signs of heart failure (dyspnoea, reduced exercise capacity, edema tendency), chest pain, palpitations / arrhythmias / syncope, and (potentially) lethal clinical conditions such as cardiogenic shock or sudden cardiac death. Predictors of increased mortality are syncopes, malignant arrhythmias EF≤35% or heart failure NYHA III-IV. ICD implantation is recommended <3 months after manifestation only in exceptional situations (e.g. following resuscitation). The European Society of Cardiology (ESC) issued a IIa recommendation in 2015 for the indication of ICD vest fitting as "bridging" until the acute phase subsides (possible normalization of left ventricular pumping function with reduced probability of malignant cardiac arrhythmias) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability is necessary. The observation, 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 with diagnosed myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.

The study is a prospective multicenter registry study. All potentially stressful measures and examinations such as blood sampling and echocardiography - except for follow-up MRI examinations - are carried out at our centre as standard clinical progress assessment, even independently of participation in the registry. The indication for biomonitor implantation is given after initial screening by means of a 24h-LZ-ECG with positive results (detection of ventricular arrhythmias). The registry study is performed with approved IECDs (Implantable electronic cardiovascular devices: Biomonitor (BioMonitor 2-AF, BioMonitor 3-AF (after release)), Biotronik® ICD) as well as WCD (Wearable Cardioverter Defibrillator, Zoll® LifeVest) and Biotronik® Cardio Messenger. The implantation is carried out exclusively according to the indication/testing guidelines. Thus, there are no risks or disadvantages for the participating patient.

The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias in patients with diagnosed myocarditis and to identify potential predictive factors for their occurrence.

Secondary goal is to analyze the long-term survival and need for heart transplantation and to identify MRI/echocardiographic parameters as determinants of arrhythmias.

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Christina Moser; Phone Number: 0049 (0) 931 201 39946; Email: moser_c@ukw.de

Study Locations

• Germany
  • Bayern
    • Würzburg, Bayern, Germany, 97080
      • Recruiting
      • Wuerzburg University Hospital
      • Contact: Christina Moser; Phone Number: 004993120139946; Email: moser_c@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biomonitor only; Patients receive a Biomonitor only	Device: Biomonitor; Patients receive a Biomonitor only; Device: Implantable Cardioverter-Defibrillator (ICD); Patients receive an Implantable Cardioverter-Defibrillator (ICD)
Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor; Patients receive a Wearable Cardioverter-Defibrillator (Life Vest) combined with a Biomonitor	Device: Biomonitor; Patients receive a Biomonitor only; Device: Implantable Cardioverter-Defibrillator (ICD); Patients receive an Implantable Cardioverter-Defibrillator (ICD); Device: Life Vest; Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally
ICD Implantation; Patients receive an ICD only	Device: Implantable Cardioverter-Defibrillator (ICD); Patients receive an Implantable Cardioverter-Defibrillator (ICD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: Hannover Medical School; MVZ Leopoldina GmbH; Brandenburg Medical School Theodor Fontane
• Investigators: Principal Investigator: Peter Nordbeck, MD, PhD, University Hospital Wuerzburg; Principal Investigator: Jonas Muentze, MD, University Hospital Wuerzburg

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ICD; Myocarditis; Ventricular Arrythmia; Life Vest; BioMonitor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Arrhythmias, Cardiac; Myocarditis
• Other Study ID Numbers: IT-II-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No