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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Pologne, 35-301
- Clinical Provincial Hospital No. 2 in Rzeszow
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UR-RNA-VA-2025-01
- 2025/09/X/NZ2/00644 (Autre subvention/numéro de financement: National Science Centre, Poland)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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