Heart Failure With Reduced Ejection FractionNCT07795892
Circulating RNA Markers of Ventricular Arrhythmias in Remotely Monitored Patients With Post-Infarction Heart Failure and Implanted Cardioverter-Defibrillators
An observational study of Heart Failure With Reduced Ejection Fraction and Ventricular Arrhythmia, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Ventricular Arrhythmia, Ischemic Cardiomyopathy
- What is being tested?
- Circulating Small RNA Profiling
- How many people
- 57 participants
- Where
- 1 sitePoland
- Study dates
- 12 Mar 2026to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age younger than 18 years
- Lack of informed consent or withdrawal of consent
- Concurrent participation in another study evaluating a drug or therapeutic intervention
Trial locations and contacts
1 site in 1 country.
Poland1 site
Clinical Provincial Hospital No. 2 in Rzeszow
Rzeszów, Podkarpackie Voivodeship, 35-301
About this study
Official 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
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.
Read the 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.
- Conditions
- Heart Failure With Reduced Ejection Fraction, Ventricular Arrhythmia, Ischemic Cardiomyopathy
- Being tested
- Circulating Small RNA Profiling
- Keywords
- microRNA, Circulating RNA, Implantable Cardioverter-Defibrillator, Remote Monitoring, Ventricular Tachycardia, Ventricular Fibrillation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Small RNA ProfilingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Circulating Small RNA Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From blood collection through 6 months
Secondary outcomes (1)
Long-Term 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 during extended routine remote monitoring.
Measured: From blood collection through 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start12 Mar 2026
- Primary completion12 Sep 2026 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Principal investigator, Mariusz Wójcik, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795892
- Sponsor's protocol ID
- UR-RNA-VA-2025-01
- Other IDs
- 2025/09/X/NZ2/00644
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07795892
- Acronym / sponsor ID
- UR-RNA-VA-2025-01
- Conditions
- Heart Failure With Reduced Ejection Fraction, Ventricular Arrhythmia, Ischemic Cardiomyopathy
- Keywords
- microRNA, Circulating RNA, Implantable Cardioverter-Defibrillator, Remote Monitoring, Ventricular Tachycardia, Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Sep 2026 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Infarction Heart Failure With Implanted Defibrillator | – | Diagnostic Test: Circulating Small RNA ProfilingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age younger than 18 years
- Lack of informed consent or withdrawal of consent
- Concurrent participation in another study evaluating a drug or therapeutic intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating Small RNA ProfilingPeripheral 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. | Diagnostic test | Post-Infarction Heart Failure With Implanted Defibrillator |
Primary outcome
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.
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.
1 secondary outcome
Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Time frame: From blood collection through 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction and Ventricular Arrhythmia, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.