Myocardial Fibrosis in Patients With Permanent Pacemakers
1 other identifier
observational
300
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 11, 2024
April 1, 2024
4 years
June 13, 2023
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in indicators of myocardial fibrosis
Changes in indicators of myocardial fibrosis in patients with cardiac arrhythmias depending on type of treatment
June 2023 - June 2028
Secondary Outcomes (2)
Changes in echocardiography parameters
June 2023 - June 2028
Changes in quality of life
June 2023 - June 2028
Study Arms (2)
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).
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.
Interventions
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).
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.
Eligibility Criteria
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).
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ryazan State Medical University
Ryazan, 390026, Russia
Biospecimen
Extraction of peripheral venous blood to determine the level of myocardial fibrosis markers (Halitin-3, ST2);
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Igor Suchkov, MD DMedSc
Ryazan State Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 27, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
April 11, 2024
Record last verified: 2024-04