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

NCT05168189 | Unknown FDA Drug

• 1 other identifier: Ivabradine-induced AF in CCS
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

AF - Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ivabradine Group

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

Drug: Ivabradine; Diagnostic Test: transthoracic echo; Device: 24 hours holter

Non-Ivabradine Group

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

Diagnostic Test: transthoracic echo; Device: 24 hours holter

Interventions

Ivabradine DRUG

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

Also known as: Procoralan , Corlanor,

Ivabradine Group

transthoracic echo DIAGNOSTIC_TEST

performing baseline transthoracic echo for all patients to exclude any chamber dilatation

Also known as: TTE

Ivabradine Group; Non-Ivabradine Group

24 hours holter DEVICE

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

Ivabradine Group; Non-Ivabradine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic coronary syndrome attending an outpatient clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 28958335 BACKGROUND

• 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.

  PMID: 16638640 BACKGROUND

• 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.

  PMID: 7457467 BACKGROUND

• 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.

  PMID: 3591616 BACKGROUND

• 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.

  PMID: 9747448 BACKGROUND

• 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.

  PMID: 20802247 BACKGROUND

• 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.

  PMID: 21914029 BACKGROUND

• 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.

  PMID: 32685161 BACKGROUND

• 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.

  PMID: 15813619 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Salwa R. Demitry, PhD

  Professor at cardiovascular medicine department , assiut university

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman R. Kamel, MBBS

CONTACT

+20 01002251849; Ab.ragabk@gmail.com

Heba M. El-Naggar, PhD

CONTACT

+20 01001963100; heba_m_elnaggar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 28, 2021

Record last verified: 2021-12