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OpenTrials
Active, not recruiting

NCT Number: NCT07795892

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Ischemic Cardiomyopathy Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Arrhythmia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Provincial Hospital No. 2 in Rzeszow

Rzeszów, Podkarpackie Voivodeship, 35-301, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circulating Small RNA Profiling

Diagnostic Test

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.

Primary outcomes

  1. Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype

    Time frame: 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.

  2. Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy

    Time frame: 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 outcomes

  1. Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Collaborators

  • National Science Centre, Poland

Registry information

Official study title

The Role of Non-Coding RNA Molecules as Potential Markers of Ventricular Arrhythmias in Patients With Post-Myocardial Infarction Heart Failure and Implanted Cardioverter-Defibrillators Undergoing Remote Monitoring

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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