Circulating RNA Markers of Ventricular Arrhythmias in Remotely Monitored Patients With Post-Infarction Heart Failure and Implanted Cardioverter-Defibrillators

Condition(s) studied

Investigational drug(s) / intervention(s)

Circulating 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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