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

AF - Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05168189
• Other study ID #: Ivabradine-induced AF in CCS
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: Abdelrahman R. Kamel, MBBS
• Phone: +20 01002251849
• Email: Ab.ragabk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• AF - Atrial Fibrillation
• Atrial Fibrillation

Intervention

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

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

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. Review. — View Citation

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. Epub 2006 Mar 27. Review. — View Citation

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. — View Citation

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. Erratum in: Eur Heart J. 2011 May;32(9):1172. — View Citation

Hoppe UC, Beuckelmann DJ. Characterization of the hyperpolarization-activated inward current in isolated human atrial myocytes. Cardiovasc Res. 1998 Jun;38(3):788-801. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect the incidence of Ivabradine-induced AF in patients with chronic coronary syndrome	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