AF - Atrial FibrillationNCT05168189
the Role of Ivabradine in Causing AF in Patients With Chronic Coronary Syndrome
An observational study of AF - Atrial Fibrillation, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AF - Atrial Fibrillation
- What is being tested?
- Ivabradine, transthoracic echo and 24 hours holter
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic coronary syndrome attending an outpatient clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- AF - Atrial Fibrillation
- Being tested
- Ivabradine, transthoracic echo, 24 hours holter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Procoralan , Corlanor,
follow up chronic coronary syndrome patients receiving Ivabradine for ( 6 months ) if the participants develop atrial fibrillation using 24 hours holter .
transthoracic echoDiagnostic test
Also called TTE
performing baseline transthoracic echo for all patients to exclude any chamber dilatation
24 hours holterDevice
perform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine Group | patients with chronic coronary syndrome using Ivabradine for heart rate control or as anti-anginal treatment. Receives: 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. Receives: Diagnostic Test: transthoracic echo; Device: 24 hours holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the start of Ivabradine treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study startAug 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AF - Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ragab Kamel, Assiut University
- Investigators
- Salwa R. Demitry, PhD, Study director, Professor at cardiovascular medicine department , assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168189
- Sponsor's protocol ID
- Ivabradine-induced AF in CCS
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
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.
PubMed 28958335DiFrancesco 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.
PubMed 16638640Dyer 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.
PubMed 7457467Kannel 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.
PubMed 3591616Hoppe 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.
PubMed 9747448European 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.
PubMed 20802247Suenari 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.
PubMed 21914029Abdelnabi 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.
PubMed 32685161Salaria 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.
PubMed 15813619
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine and Its Role in the Development of Atrial Fibrillation in Patients With Chronic Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05168189
- Acronym / sponsor ID
- Ivabradine-induced AF in CCS
- Conditions
- AF - Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine Group | – | Drug: Ivabradine, Diagnostic Test: transthoracic echo, Device: 24 hours holterpatients with chronic coronary syndrome using Ivabradine for heart rate control or as anti-anginal treatment. |
| Non-Ivabradine Group | – | Diagnostic Test: transthoracic echo, Device: 24 hours holterpatients with chronic coronary syndrome NOT using Ivabradine for heart rate control or as anti-anginal treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic coronary syndrome attending an outpatient clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineAlso: Procoralan , Corlanor,follow up chronic coronary syndrome patients receiving Ivabradine for ( 6 months ) if the participants develop atrial fibrillation using 24 hours holter . | Drug | Ivabradine Group |
| transthoracic echoAlso: TTEperforming baseline transthoracic echo for all patients to exclude any chamber dilatation | Diagnostic test | Ivabradine Group, Non-Ivabradine Group |
| 24 hours holterperform 24 hours Holter monitoring for all patients at the start of the study and follow up after 6 months | Device | Ivabradine Group, Non-Ivabradine Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 28958335Koruth 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.
- Background: PubMed 16638640DiFrancesco 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.
- Background: PubMed 7457467Dyer 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.
- Background: PubMed 3591616Kannel 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.
- Background: PubMed 9747448Hoppe 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.
- Background: PubMed 20802247European 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.
- Background: PubMed 21914029Suenari 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.
- Background: PubMed 32685161Abdelnabi 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.
- Background: PubMed 15813619Salaria 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.
Related trials for AF - Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa R. Demitry, PhD study director
Professor at cardiovascular medicine department , assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of AF - Atrial Fibrillation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman R. Kamel, MBBS (+20 01002251849, Ab.ragabk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the incidence of Ivabradine-induced AF in patients with chronic coronary syndrome (time frame: 6 months after the start of Ivabradine treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168189, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.