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

Ventricular Arrythmia Clinical Trial

— AIM-ICD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04264455
• Other study ID #: IT-II-2019
• Status: Recruiting
• Start date: October 24, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Wuerzburg University Hospital
• Contact: Christina Moser
• Phone: 0049 (0) 931 201 39946
• Email: moser_c[@]ukw.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Myocarditis
• Myocarditis Acute
• Ventricular Arrythmia

Intervention

Device:
• Biomonitor
Patients receive a Biomonitor only
• Life Vest
Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally
• Implantable Cardioverter-Defibrillator (ICD)
Patients receive an Implantable Cardioverter-Defibrillator (ICD)

Locations

Country	Name	City	State
Germany	Wuerzburg University Hospital	Würzburg	Bayern

Sponsors (4)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Brandenburg Medical School Theodor Fontane, Hannover Medical School, MVZ Leopoldina GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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