The Use of Flecainide for Treatment of Atrial Fibrillation

NCT05084495 | Completed

• 1 other identifier: Tambocor_prosp_01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of AF-free months

  During the 12 month follow up

• Frequency of side effects

  During the 12 month follow up

• Risk of pro-arrhythmias

  During the 12 month follow up

• Mortality

  During the 12 month follow up

Interventions

Global peak atrial longitudinal strain and ECG DIAGNOSTIC_TEST

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

Eligibility Criteria

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

Study Population

For patients with troublesome fibrillation burden, there are about as many ways to initiate and follow up treatment with Flecainide as there are Swedish hospitals. Although it was 30 years ago that the CAST study showed that Flecainide should not be given to patients with ischemic or structural heart disease, there is a lack of knowledge about which patient characteristics predict an effective and safe treatment. Today, the clinician is forced to use Flecainide according to the "trial-and-error" method, you simply have to see which patients benefit from the drug by trying. Regardless of the effect, patients are at risk of serious proarrhythmias and side effects.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Clinical Sciences, Helsingborg Medical Faculty Lund University

Helsingborg, Skåne County, 25187, Sweden

Location

Related Publications (6)

• 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.

  PMID: 25717355 BACKGROUND

• 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.

  PMID: 21138930 BACKGROUND

• 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.

  PMID: 2473403 BACKGROUND

• 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.

  PMID: 2233383 BACKGROUND

• 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.

  PMID: 29848496 BACKGROUND

• 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.

  PMID: 20133512 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Bjarne Madsen Härdig, RN, PhD

  Lund University and Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 19, 2021
• Study Start: February 1, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)