Heart Failure With Reduced Ejection Fraction, Ischemic Cardiomyopathy, Ventricular Arrhythmia
Conditions
Keywords
microRNA, Circulating RNA, Implantable Cardioverter-Defibrillator, Remote Monitoring, Ventricular Tachycardia, Ventricular Fibrillation
Brief summary
This prospective observational study evaluates whether circulating small non-coding RNAs, particularly microRNAs, are associated with ventricular arrhythmias in patients with post-myocardial infarction heart failure who have an implanted cardioverter-defibrillator and are followed by remote monitoring. Blood samples were collected from 57 participants. Small RNA profiles are analyzed in relation to ventricular tachycardia or ventricular fibrillation episodes recorded by the implanted device. Participants are not assigned to any treatment or intervention as part of this study. The initial analysis includes six months of follow-up, with longer-term observational follow-up planned.
Detailed description
This is a single-cohort prospective observational biomarker study in patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator who are followed through remote device monitoring. Peripheral blood was collected from 57 participants for analysis of circulating small RNAs. Following laboratory quality control, including assessment of hemolysis and sequencing quality, 48 samples were included in the primary molecular analysis. Small RNA sequencing is used to characterize circulating RNA profiles, with the main analyses focusing on microRNAs. RNA profiles are evaluated in relation to clinically relevant ventricular arrhythmias documented by the implanted device, including sustained ventricular tachycardia or ventricular fibrillation requiring antitachycardia pacing or shock. The primary prospective observation period is six months after blood collection. Continued long-term follow-up through remote monitoring is planned through March 2029. Existing clinical information and device-recorded arrhythmia history may also be used for exploratory analyses. No study-specific treatment is assigned and routine clinical management is not altered by participation. The objective is to identify circulating RNA markers associated with an arrhythmogenic phenotype and to generate candidates for subsequent validation.
Interventions
DIAGNOSTIC_TESTCirculating Small RNA Profiling
Peripheral blood collection followed by laboratory isolation and sequencing of circulating small RNAs, with primary focus on microRNAs. The molecular results are analyzed as research biomarkers and are not used to assign treatment or alter routine clinical management.
Sponsors
University of Rzeszow
National Science Centre, Poland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Post-myocardial infarction heart failure * Previous implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator * Participation in a remote monitoring program for the implanted device * Written informed consent
Exclusion criteria
* Age younger than 18 years * Lack of informed consent or withdrawal of consent * Concurrent participation in another study evaluating a drug or therapeutic intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype | At blood collection; arrhythmia phenotype determined from device records available through blood collection | Normalized expression levels and log2 fold changes of circulating small non-coding RNAs, primarily microRNAs, are compared between participants with and without device-documented life-threatening ventricular arrhythmias or appropriate ICD therapy. Statistical testing includes correction for multiple comparisons. |
| Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy | From blood collection through 6 months | Number of participants with at least one device-confirmed episode of sustained ventricular tachycardia or ventricular fibrillation treated with antitachycardia pacing or an ICD shock. Events are identified through routine remote device monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy | From blood collection through 3 years | Number of participants with at least one device-confirmed episode of sustained ventricular tachycardia or ventricular fibrillation treated with antitachycardia pacing or an ICD shock during extended routine remote monitoring. |
Countries
Poland
Outcome results
None listed