FibrosisNCT05920226
Myocardial Fibrosis in Patients With Permanent Pacemakers
An observational study of Fibrosis and Atrial Fibrillation, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- pacemakers implantation and assessment of cardiac function and cardiac fibrosis and assessment of cardiac function and cardiac fibrosis
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2023to 1 Jul 2028
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 150 patients with cardiac pathology and arrhythmia not requiring pacemaker implantation and 150 patients with cardiac pathology and arrhythmia requiring pacemaker implantation (with different localization of the right ventricular lead).
Who may be able to join
- men or women over 60 years of age
- . signed informed consent form
- . presence of cardiac pathology and arrhythmia requiring pacemakers implantation (group A).
- . presence of cardiac pathology and arrhythmia not requiring pacemaker implantation (group B).
Who cannot join
- . active cancer or remission period less than 5 years;
- . decompensated somatic pathology;
- . active viral hepatitis, HIV or syphilis;
- . men or women younger than 60 years of age or older than 85 years of age;
- . withdrawn consent.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right ventricle according to echocardiographic and electrocardiographic parameters, congestive heart failure progression, patients' quality of life and follow-up therapy of patients with identified myocardial fibrosis with existing pacemaker.
Study of changes in echocardiography, electrocardiography, myocardial fibrosis markers, the quality of life of patients will allow to choose the most optimal localization of the ventricular electrode during implantation of the permanent pacemakers system in order to improve the quality of life of the patients.
Read the detailed description
Anticipated design of the study: an open, prospective, study, with parallel groups of patients according to ICH GCP ((International Conference on Harmonisation - Good Clinical Practice) criteria.
The study will involve 300 patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation, who will be allocated into 2 groups: group 1 - patients who require a permanent pacemaker placement; group 2 - patients who do not require a permanent pacemaker placement.
Patients involved in the study will undergo peripheral venous blood sampling to determine the level of myocardial fibrosis markers (Halitin-3, ST2), electrocardiography (assessment of the type of bradyarrhythmia, assessment of the presence/absence and type of intraventricular conductivity disorder, estimation of the width of the QRS complex, direction of the electric axis of the heart), echocardiography (evaluation of ejection fraction, heart chamber size, mitral and tricuspidal manifestation, interventricular delay), contrast-enhanced cardiac magnetic resonance imaging (MRI), quality of life assessment using the Aquarel questionnaire. All procedures will be repeated at time points as per protocol.
Specific information for Group A patients: there will be different variants of localization of the right ventricular lead (top of the right ventricle, the upper third of the ventricular septum, the middle third of the ventricular septum, the lower third of the ventricular septum, front wall of the right ventricle, lower wall of the right ventricle, parahisial region, His bundle). The analysis of the subgroups will be carried out according to the following criteria: electrode localization, main indication for pacemakers implantation, pacemakers model, type of initial intraventricular conductivity disorder.
- Conditions
- Fibrosis, Atrial Fibrillation, Atrial Flutter
- Being tested
- pacemakers implantation and assessment of cardiac function and cardiac fibrosis, assessment of cardiac function and cardiac fibrosis
- Medical subject headings
- Fibrosis, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemakers implantation and assessment of cardiac function and cardiac fibrosisDevice
Also called Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRI
150 patients will be implanted with pacemakers. In addition to the echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers, the tests described above will be repeated at 1 (V1), 12 (V2), 24 (V3) months after inclusion. Echocardiography and peripheral venous blood sampling for myocardial fibrosis markers detection will be repeated to all patients before pacemakers implantation and after 6,12 and 24 months of observation period. Contrast-enhanced cardiac magnetic resonance imaging (MRI) will be performed before pacemaker implantation and 6 months after surgery.
In addition, pacemakers programming data will be evaluated after 1, 12, 24 months after inclusion in the study (atrioventricular delay, percentage of ventricular stimulation, episodes of high atrial frequency, fibrillation/atrial flutter, ventricular tachycardia).
assessment of cardiac function and cardiac fibrosisDiagnostic test
Also called Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRI
The patients who do not require a pacemaker placement will undergo diagnostic testing such as echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers.
| Study group | Role | What they receive |
|---|---|---|
| A: 150 patients with indications for pacemakers implantation; | * men or women over 60 years of age
* with signed informed consent form
* in presence of cardiac pathology and arrhythmia requiring pacemakers implantation.
* without active cancer or remission period less than 5 years;
* without decompensated somatic pathology;
* without active viral hepatitis, HIV or syphilis.
Patients will be under observation for 2 years (inclusion in the study, visit 1, 12, 24 months after inclusion in the study). Receives: Device: pacemakers implantation and assessment of cardiac function and cardiac fibrosis | |
| B: 150 patients without pacemakers implantation; | * men or women over 60 years of age
* with signed informed consent form
* in presence of cardiac pathology and arrhythmia not requiring pacemaker implantation.
* without active cancer or remission period less than 5 years;
* without decompensated somatic pathology;
* without active viral hepatitis, HIV or syphilis. Receives: Diagnostic Test: assessment of cardiac function and cardiac fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in indicators of myocardial fibrosis
Changes in indicators of myocardial fibrosis in patients with cardiac arrhythmias depending on type of treatment
Measured: June 2023 - June 2028
Secondary outcomes (2)
Changes in echocardiography parameters
Changes in echocardiography parameters such as ejection fraction, valve regurgitation.
Measured: June 2023 - June 2028
Changes in quality of life
Changes in quality of life in patients with cardiac arrhythmias depending on type of treatment
Measured: June 2023 - June 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suchkov Igor A., Ryazan State Medical University
- Investigators
- Igor Suchkov, MD DMedSc, Principal investigator, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920226
- Sponsor's protocol ID
- Fibrosis05/23
- Status last verified
- Apr 2024
- First submitted
- 13 Jun 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Fibrosis in Patients With Permanent Pacemakers
- ClinicalTrials.gov ID
- NCT05920226
- Acronym / sponsor ID
- Fibrosis05/23
- Conditions
- Fibrosis, Atrial Fibrillation, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 27 Jun 2023 (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.
Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right ventricle according to echocardiographic and electrocardiographic parameters, congestive heart failure progression, patients' quality of life and follow-up therapy of patients with identified myocardial fibrosis with existing pacemaker.
Study of changes in echocardiography, electrocardiography, myocardial fibrosis markers, the quality of life of patients will allow to choose the most optimal localization of the ventricular electrode during implantation of the permanent pacemakers system in order to improve the quality of life of the patients.
Detailed description
Anticipated design of the study: an open, prospective, study, with parallel groups of patients according to ICH GCP ((International Conference on Harmonisation - Good Clinical Practice) criteria.
The study will involve 300 patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation, who will be allocated into 2 groups: group 1 - patients who require a permanent pacemaker placement; group 2 - patients who do not require a permanent pacemaker placement.
Patients involved in the study will undergo peripheral venous blood sampling to determine the level of myocardial fibrosis markers (Halitin-3, ST2), electrocardiography (assessment of the type of bradyarrhythmia, assessment of the presence/absence and type of intraventricular conductivity disorder, estimation of the width of the QRS complex, direction of the electric axis of the heart), echocardiography (evaluation of ejection fraction, heart chamber size, mitral and tricuspidal manifestation, interventricular delay), contrast-enhanced cardiac magnetic resonance imaging (MRI), quality of life assessment using the Aquarel questionnaire. All procedures will be repeated at time points as per protocol.
Specific information for Group A patients: there will be different variants of localization of the right ventricular lead (top of the right ventricle, the upper third of the ventricular septum, the middle third of the ventricular septum, the lower third of the ventricular septum, front wall of the right ventricle, lower wall of the right ventricle, parahisial region, His bundle). The analysis of the subgroups will be carried out according to the following criteria: electrode localization, main indication for pacemakers implantation, pacemakers model, type of initial intraventricular conductivity disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: 150 patients with indications for pacemakers implantation; | – | Device: pacemakers implantation and assessment of cardiac function and cardiac fibrosis* men or women over 60 years of age * with signed informed consent form * in presence of cardiac pathology and arrhythmia requiring pacemakers implantation. * without active cancer or remission period less than 5 years; * without decompensated somatic pathology; * without active viral hepatitis, HIV or syphilis. Patients will be under observation for 2 years (inclusion in the study, visit 1, 12, 24 months after inclusion in the study). |
| B: 150 patients without pacemakers implantation; | – | Diagnostic Test: assessment of cardiac function and cardiac fibrosis* men or women over 60 years of age * with signed informed consent form * in presence of cardiac pathology and arrhythmia not requiring pacemaker implantation. * without active cancer or remission period less than 5 years; * without decompensated somatic pathology; * without active viral hepatitis, HIV or syphilis. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with cardiac pathology and arrhythmia not requiring pacemaker implantation and 150 patients with cardiac pathology and arrhythmia requiring pacemaker implantation (with different localization of the right ventricular lead).
Key inclusion criteria (4 listed)
- men or women over 60 years of age
- . signed informed consent form
- . presence of cardiac pathology and arrhythmia requiring pacemakers implantation (group A).
- . presence of cardiac pathology and arrhythmia not requiring pacemaker implantation (group B).
Key exclusion criteria (5 listed)
- . active cancer or remission period less than 5 years;
- . decompensated somatic pathology;
- . active viral hepatitis, HIV or syphilis;
- . men or women younger than 60 years of age or older than 85 years of age;
- . withdrawn consent.
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 |
|---|---|---|
| pacemakers implantation and assessment of cardiac function and cardiac fibrosisAlso: Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRI150 patients will be implanted with pacemakers. In addition to the echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers, the tests described above will be repeated at 1 (V1), 12 (V2), 24 (V3) months after inclusion. Echocardiography and peripheral venous blood sampling for myocardial fibrosis markers detection will be repeated to all patients before pacemakers implantation and after 6,12 and 24 months of observation period. Contrast-enhanced cardiac magnetic resonance imaging (MRI) will be performed before pacemaker implantation and 6 months after surgery. In addition, pacemakers programming data will be evaluated after 1, 12, 24 months after inclusion in the study (atrioventricular delay, percentage of ventricular stimulation, episodes of high atrial frequency, fibrillation/atrial flutter, ventricular tachycardia). | Device | A: 150 patients with indications for pacemakers implantation; |
| assessment of cardiac function and cardiac fibrosisAlso: Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRIThe patients who do not require a pacemaker placement will undergo diagnostic testing such as echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers. | Diagnostic test | B: 150 patients without pacemakers implantation; |
Primary outcome
Changes in indicators of myocardial fibrosis
Time frame: June 2023 - June 2028
Changes in indicators of myocardial fibrosis in patients with cardiac arrhythmias depending on type of treatment
2 secondary outcomes
Changes in echocardiography parameters
Time frame: June 2023 - June 2028
Changes in quality of life
Time frame: June 2023 - June 2028
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 11 Apr 2024.
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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.
Igor Suchkov, MD DMedSc principal investigator
Ryazan State Medical University
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 Fibrosis and Atrial Fibrillation, run by Ryazan State Medical University at 1 site in Russia.
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 4 inclusion and 5 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 11 Apr 2024. 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 Russia. 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?
Changes in indicators of myocardial fibrosis (time frame: June 2023 - June 2028). 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 11 Apr 2024.