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

NCT07795892 | Active Not Recruiting

• 2 other identifiers: UR-RNA-VA-2025-012025/09/X/NZ2/00644
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy; Heart Failure With Reduced Ejection Fraction; Ventricular Arrhythmia

Keywords

microRNA; Circulating RNA; Implantable Cardioverter-Defibrillator; Remote Monitoring; Ventricular Tachycardia; Ventricular Fibrillation

Outcome Measures

Primary Outcomes (2)

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

  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.

  At blood collection; arrhythmia phenotype determined from device records available through blood collection

• Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy

  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.

  From blood collection through 6 months

Secondary Outcomes (1)

• Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy

  From blood collection through 3 years

Study Arms (1)

Post-Infarction Heart Failure With Implanted Defibrillator

Patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator undergoing routine remote monitoring. Circulating small RNA profiles are evaluated in relation to device-recorded ventricular arrhythmias. No treatment is assigned by the study.

Diagnostic Test: Circulating Small RNA Profiling

Interventions

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.

Post-Infarction Heart Failure With Implanted Defibrillator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving cardiology outpatient care for post-myocardial infarction heart failure who have an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator and are followed through a remote monitoring program.

You may qualify if:

• 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

You may not qualify if:

• Age younger than 18 years
• Lack of informed consent or withdrawal of consent
• Concurrent participation in another study evaluating a drug or therapeutic intervention

Sponsors & Collaborators

• University of Rzeszow: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

Clinical Provincial Hospital No. 2 in Rzeszow

Rzeszów, Podkarpackie Voivodeship, 35-301, Poland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: March 12, 2026
• Primary Completion: September 12, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

PL (1)