Circulating RNA Markers of Ventricular Arrhythmias in Remotely Monitored Patients With Post-Infarction Heart Failure and Implanted Cardioverter-Defibrillators
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Poland, 35-301
- Clinical Provincial Hospital No. 2 in Rzeszow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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At blood collection; arrhythmia phenotype determined from device records available through blood collection
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Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Time Frame: From blood collection through 6 months
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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.
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From blood collection through 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Time Frame: From blood collection through 3 years
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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.
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From blood collection through 3 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UR-RNA-VA-2025-01
- 2025/09/X/NZ2/00644 (Other Grant/Funding Number: National Science Centre, Poland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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