Targeted pharmacological reversal of electrical remodeling after cardioversion

ISRCTN	ISRCTN62728743
DOI	https://doi.org/10.1186/ISRCTN62728743
ClinicalTrials.gov (NCT)	NCT00215774
Protocol serial number	AFNET-B11
Sponsor	German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
Funders	German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) with funds of the German Research Foundation (Deutsche Forschunggemeinschaft [DFG]) and the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany), Meda Pharma (Germany)

Submission date: 06/04/2005
Registration date: 02/08/2005
Last edited: 06/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paulus Kirchhof
Scientific

University of Birmingham Centre for Cardiovascular Sciences
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 4148855
Email	p.kirchhof@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Targeted pharmacological reversal of electrical remodeling after cardioversion
Study acronym	Flec-SL
Study objectives	Targeted, short-term pharmacological reversal of electrical remodeling is not inferior to prevent recurrent AF after cardioversion when compared to standard long-term antiarrhythmic medication. On 05/10/2009 the following changes were made to the trial record : 1. The target number of participants was changed from 760 to 575. 2. The overall trial end date was changed from 30/06/2008 to 01/05/2011. On 13/10/2009 the target number of participants was changed from 575 to 635.
Ethics approval(s)	Ethics Committee of Ärztekammer Westfalen-Lippe and the Faculty of Medicine, Westfälischen Wilhelms University of Münster, November 2004, ref: 4 VII Kirchhof
Health condition(s) or problem(s) studied	Atrial fibrillation (AF)
Intervention	Targeted, short-term pharmacological reversal of electrical remodeling is not inferior to prevent recurrent AF after cardioversion when compared to standard long-term antiarrhythmic medication.
Intervention type	Other
Primary outcome measure(s)	Time to first recurrence of persistent AF
Key secondary outcome measure(s)	1. Time to first occurrence of a documented relapse of atrial fibrillation 2. Number of patients with persistent AF after 6 months 3. Number and total duration of documented AF episodes 4. Time to termination of trial medication 5. Number of hospitalizations due to atrial fibrillation 6. Number of visits without hospitalization 7. Number of serious adverse events of special interest 8. Evolution of left ventricular function 9. Quality of life
Completion date	01/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	635
Key inclusion criteria	1. Documented persistent atrial fibrillation 2. Age of 18 years 3. Documented oral anticoagulation (international normalized ratio [INR] ≥2) for at least three weeks prior to inclusion, or exclusion of left atrial thrombi by trans-esophageal echocardiography 4. Written informed consent of the patient
Key exclusion criteria	Exclusion criteria are based on the approval information of flecainide and include, among others, patients with known coronary artery disease or typical angina pectoris, patients with depressed left ventricular ejection fraction (<40%), patients with severely depressed renal or hepatic function, patients with overt thyroid disease, and patients with known Brugada syndrome, sinus node dysfunction or higher degree AV nodal block.
Date of first enrolment	01/03/2005
Date of final enrolment	31/10/2009

Locations

Countries of recruitment

United Kingdom
England
Germany

Study participating centre

University of Birmingham Centre for Cardiovascular Sciences

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	21/07/2012	Yes	No
Results article	results	18/09/2012	Yes	No
Results article	results	09/10/2013	Yes	No
Protocol article	protocol	01/11/2005	Yes	No
Other publications	publication with some data on the Flec-SL trial:	01/11/2007	Yes	No