The Use of Flecainide for Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084495
• Other study ID #: Tambocor_prosp_01
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Lund University
• Contact: Bjarne Madsen Härdig, RN, PhD
• Phone: +46 42 4061613
• Email: bjarne.madsen_hardig[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

Description:

Study synopsis for the Tambocor Prospective study Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation. Ethics: Informed Concent prior to inclusion. Follow up after baseline: 4 visits during 12 month. End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide. Evaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV. The follow up visits: Baseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire 4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation.
• The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals.
• Age >18 years

Exclusion Criteria:

• Flecainide treatment with other indication than atrial fibrillation (including atrial flutter).
• No secure date for treatment start.
• Age <18 years

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Global peak atrial longitudinal strain and ECG
During the follow-up period the patient will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected

Locations

Country	Name	City	State
Sweden	Clinical Sciences, Helsingborg Medical Faculty Lund University	Helsingborg	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Aliot E, Capucci A, Crijns HJ, Goette A, Tamargo J. Twenty-five years in the making: flecainide is safe and effective for the management of atrial fibrillation. Europace. 2011 Feb;13(2):161-73. doi: 10.1093/europace/euq382. Epub 2010 Dec 7. — View Citation

Andrikopoulos GK, Pastromas S, Tzeis S. Flecainide: Current status and perspectives in arrhythmia management. World J Cardiol. 2015 Feb 26;7(2):76-85. doi: 10.4330/wjc.v7.i2.76. — View Citation

Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med. 1989 Aug 10;321(6):406-12. doi: 10.1056/NEJM198908103210629. — View Citation

Kuppahally SS, Akoum N, Burgon NS, Badger TJ, Kholmovski EG, Vijayakumar S, Rao SN, Blauer J, Fish EN, Dibella EV, Macleod RS, McGann C, Litwin SE, Marrouche NF. Left atrial strain and strain rate in patients with paroxysmal and persistent atrial fibrillation: relationship to left atrial structural remodeling detected by delayed-enhancement MRI. Circ Cardiovasc Imaging. 2010 May;3(3):231-9. doi: 10.1161/CIRCIMAGING.109.865683. Epub 2010 Feb 4. — View Citation

Macfarlane PW, Devine B, Latif S, McLaughlin S, Shoat DB, Watts MP. Methodology of ECG interpretation in the Glasgow program. Methods Inf Med. 1990 Sep;29(4):354-61. — View Citation

Skov MW, Ghouse J, Kuhl JT, Platonov PG, Graff C, Fuchs A, Rasmussen PV, Pietersen A, Nordestgaard BG, Torp-Pedersen C, Hansen SM, Olesen MS, Haunso S, Kober L, Gerds TA, Kofoed KF, Svendsen JH, Holst AG, Nielsen JB. Risk Prediction of Atrial Fibrillation Based on Electrocardiographic Interatrial Block. J Am Heart Assoc. 2018 May 30;7(11):e008247. doi: 10.1161/JAHA.117.008247. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrythmia free health status	Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start	During the 12 month follow up
Secondary	Number of AF-free months	Can we improve the number of AF-free months by a better prediction model	During the 12 month follow up
Secondary	Frequency of side effects	Can we improve the diagnostic accuracy to reduce the frequency of side effects	During the 12 month follow up
Secondary	Risk of pro-arrhythmias	Can we improve the diagnostic accuracy to reduce risk of pro-arrhythmias	During the 12 month follow up
Secondary	Mortality	Can we improve the diagnostic accuracy to reduce risk mortality	During the 12 month follow up