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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Podkarpackie Voivodeship
-
Rzeszów, Podkarpackie Voivodeship, Polen, 35-301
- Clinical Provincial Hospital No. 2 in Rzeszow
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
Tijdsspanne: 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.
|
At blood collection; arrhythmia phenotype determined from device records available through blood collection
|
|
Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Tijdsspanne: 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.
|
From blood collection through 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Tijdsspanne: 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.
|
From blood collection through 3 years
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UR-RNA-VA-2025-01
- 2025/09/X/NZ2/00644 (Ander subsidie-/financieringsnummer: National Science Centre, Poland)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .