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the Role of Ivabradine in Causing AF in Patients With Chronic Coronary Syndrome

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05168189
Collaborator
(none)
180
Enrollment
17
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is aiming to detect the possibility of Ivabradine's role in the development of atrial fibrillation in chronic coronary syndrome patients with No structural heart disease.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Ivabradine is a heart rate-lowering agent best characterized by its negative chronotropic effect on the sinoatrial node. Its unique mechanism selectively blocks the pacemaker funny channels, which are responsible for spontaneous depolarization in the sinoatrial node that regulates heart rate during sinus rhythm. It has been well established that controlling the heart rate is the main target when treating coronary artery disease and heart failure and is associated with a beneficial effect on mortality and morbidity.

According to the European Society of Cardiology guidelines for Chronic coronary syndrome, ivabradine should be considered as an anti-anginal agent in patients with sinus rhythm and heart rate of ≥70 BPM in combination with beta-blockers or when beta-blockers are not tolerated.

The If current, which is affected by ivabradine, was found to be present in the pulmonary vein myocardial sleeves, the well-recognized triggers for AF.

This may explain the risk of AF in patients receiving this drug. However, AF is commonly associated with HF and ischemic heart disease, the current two clinical indications for the use of ivabradine, hence AF in this patient population may be an association rather than a drug-induced effect.

Previously, ivabradine's heart rate reduction was thought to be exclusively due to inhibition of If channels in the sinoatrial node. However, emerging data have shown channels that maintain the If current in the free wall of both atria. These findings support the idea that the If current plays a role in the pathophysiological procedure that initiates and maintains AF.

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ivabradine and Its Role in the Development of Atrial Fibrillation in Patients With Chronic Coronary Syndrome
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Ivabradine Group

patients with chronic coronary syndrome using Ivabradine for heart rate control or as anti-anginal treatment.

Drug: Ivabradine
follow up chronic coronary syndrome patients receiving Ivabradine for ( 6 months ) if the participants develop atrial fibrillation using 24 hours holter .
Other Names:
  • Procoralan , Corlanor,

    • Diagnostic Test: transthoracic echo
    performing baseline transthoracic echo for all patients to exclude any chamber dilatation
    Other Names:
  • TTE

    • Device: 24 hours holter
    perform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months
    Non-Ivabradine Group

    patients with chronic coronary syndrome NOT using Ivabradine for heart rate control or as anti-anginal treatment.

    Diagnostic Test: transthoracic echo
    performing baseline transthoracic echo for all patients to exclude any chamber dilatation
    Other Names:
  • TTE

    • Device: 24 hours holter
    perform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months

    Outcome Measures

    Primary Outcome Measures

    1. detect the incidence of Ivabradine-induced AF in patients with chronic coronary syndrome [6 months after the start of Ivabradine treatment]

      detect the role of Ivabradine's in the development of atrial fibrillation in chronic coronary syndrome patients with No structural heart disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age range from 18 to 70 years.

    • diagnosed with Chronic Coronary syndrome according to European association guidelines of 2019.

    • Normal structural heart disease (as evident by 2D transthoracic echocardiography).

    • in sinus rhythm.

    Exclusion Criteria:

    • Patient with heart rate below 70 bpm at the start of treatment.

    • Smokers.

    • hyperthyroidism.

    • Hypertensive patients

    • Patient with bradycardia arrhythmia (sinus Bradycardia, advanced degree of heart block).

    • history of Atrial fibrillation.

    • history of Myocardial infarction, Previous PCI, or CABG.

    • Patient with Valvular heart disease.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Salwa R. Demitry, PhD, Professor at cardiovascular medicine department , assiut university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdelrahman Ragab Kamel, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05168189
    Other Study ID Numbers:
    • Ivabradine-induced AF in CCS
    First Posted:
    Dec 23, 2021
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Dec 28, 2021