the Role of Ivabradine in Causing AF in Patients With Chronic Coronary Syndrome
NCT ID: NCT05168189
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
180 participants
OBSERVATIONAL
2022-08-31
2024-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ivabradine Group
patients with chronic coronary syndrome using Ivabradine for heart rate control or as anti-anginal treatment.
Ivabradine
follow up chronic coronary syndrome patients receiving Ivabradine for ( 6 months ) if the participants develop atrial fibrillation using 24 hours holter .
transthoracic echo
performing baseline transthoracic echo for all patients to exclude any chamber dilatation
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.
transthoracic echo
performing baseline transthoracic echo for all patients to exclude any chamber dilatation
24 hours holter
perform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months
Interventions
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Ivabradine
follow up chronic coronary syndrome patients receiving Ivabradine for ( 6 months ) if the participants develop atrial fibrillation using 24 hours holter .
transthoracic echo
performing baseline transthoracic echo for all patients to exclude any chamber dilatation
24 hours holter
perform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Abdelrahman Ragab Kamel
Resident doctor
Principal Investigators
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Salwa R. Demitry, PhD
Role: STUDY_DIRECTOR
Professor at cardiovascular medicine department , assiut university
Central Contacts
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References
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Koruth JS, Lala A, Pinney S, Reddy VY, Dukkipati SR. The Clinical Use of Ivabradine. J Am Coll Cardiol. 2017 Oct 3;70(14):1777-1784. doi: 10.1016/j.jacc.2017.08.038.
DiFrancesco D. Funny channels in the control of cardiac rhythm and mode of action of selective blockers. Pharmacol Res. 2006 May;53(5):399-406. doi: 10.1016/j.phrs.2006.03.006. Epub 2006 Mar 27.
Dyer AR, Persky V, Stamler J, Paul O, Shekelle RB, Berkson DM, Lepper M, Schoenberger JA, Lindberg HA. Heart rate as a prognostic factor for coronary heart disease and mortality: findings in three Chicago epidemiologic studies. Am J Epidemiol. 1980 Dec;112(6):736-49. doi: 10.1093/oxfordjournals.aje.a113046.
Kannel WB, Kannel C, Paffenbarger RS Jr, Cupples LA. Heart rate and cardiovascular mortality: the Framingham Study. Am Heart J. 1987 Jun;113(6):1489-94. doi: 10.1016/0002-8703(87)90666-1.
Hoppe UC, Beuckelmann DJ. Characterization of the hyperpolarization-activated inward current in isolated human atrial myocytes. Cardiovasc Res. 1998 Jun;38(3):788-801. doi: 10.1016/s0008-6363(98)00047-9.
European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
Suenari K, Cheng CC, Chen YC, Lin YK, Nakano Y, Kihara Y, Chen SA, Chen YJ. Effects of ivabradine on the pulmonary vein electrical activity and modulation of pacemaker currents and calcium homeostasis. J Cardiovasc Electrophysiol. 2012 Feb;23(2):200-6. doi: 10.1111/j.1540-8167.2011.02173.x. Epub 2011 Sep 13.
Abdelnabi M, Ahmed A, Almaghraby A, Saleh Y, Badran H. Ivabradine and AF: Coincidence, Correlation or a New Treatment? Arrhythm Electrophysiol Rev. 2020 Feb 12;8(4):300-303. doi: 10.15420/aer.2019.30.2.
Salaria V, Mehta NJ, Abdul-Aziz S, Mohiuddin SM, Khan IA. Role of postoperative use of adrenergic drugs in occurrence of atrial fibrillation after cardiac surgery. Clin Cardiol. 2005 Mar;28(3):131-5. doi: 10.1002/clc.4960280306.
Other Identifiers
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Ivabradine-induced AF in CCS
Identifier Type: -
Identifier Source: org_study_id