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

December 22, 2021 updated by: Abdelrahman Ragab Kamel, Assiut University

Ivabradine and Its Role in the Development of Atrial Fibrillation in Patients With Chronic Coronary Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic coronary syndrome attending an outpatient clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect the incidence of Ivabradine-induced AF in patients with chronic coronary syndrome
Time Frame: 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.
6 months after the start of Ivabradine treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (ACTUAL)

December 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ivabradine-induced AF in CCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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