Myocardial Fibrosis in Patients With Permanent Pacemakers

NCT ID: NCT05920226

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2028-07-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

pacemakers implantation and assessment of cardiac function and cardiac fibrosis

Intervention Type: DEVICE

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).

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.

assessment of cardiac function and cardiac fibrosis

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

pacemakers implantation and assessment of cardiac function and cardiac fibrosis

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).

Intervention Type: DEVICE

assessment of cardiac function and cardiac fibrosis

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRI; Withdrawal of Peripheral venous blood samples; electrocardiography; echocardiography; contrast-enhanced cardiac MRI

Eligibility Criteria

Inclusion Criteria

1. men or women over 60 years of age

2. . signed informed consent form

3. . presence of cardiac pathology and arrhythmia requiring pacemakers implantation (group A).

4. . presence of cardiac pathology and arrhythmia not requiring pacemaker implantation (group B).

Exclusion Criteria

1. . active cancer or remission period less than 5 years;

2. . decompensated somatic pathology;

3. . active viral hepatitis, HIV or syphilis;

4. . men or women younger than 60 years of age or older than 85 years of age;

5. . withdrawn consent.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ryazan State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Suchkov Igor A.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Igor Suchkov, MD DMedSc

Role: PRINCIPAL_INVESTIGATOR

Ryazan State Medical University

Locations

Ryazan State Medical University

Ryazan, , Russia

Countries

Russia

Other Identifiers

Fibrosis05/23

Identifier Type: -

Identifier Source: org_study_id