Targeted pharmacological reversal of electrical remodeling after cardioversion
| ISRCTN | ISRCTN62728743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62728743 |
| ClinicalTrials.gov number | NCT00215774 |
| Secondary identifying numbers | AFNET-B11 |
- 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
Scientific
University of Birmingham Centre for Cardiovascular Sciences
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 4148855 |
|---|---|
| p.kirchhof@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | Time to first recurrence of persistent AF |
| Secondary outcome measures | 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 |
| Overall study start date | 01/03/2005 |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- Germany
- United Kingdom
Study participating centre
University of Birmingham Centre for Cardiovascular Sciences
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
Government
Government
Domagkstr. 11
Münster
48149
Germany
| Phone | +49 (0)251-83- 45341 |
|---|---|
| info@kompetenznetz-vorhofflimmern.de | |
| Website | http://www.kompetenznetz-vorhofflimmern.de/ |
"ROR" |
https://ror.org/01spm3d88 |
Funders
Funder type
Industry
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)
No information available
Meda Pharma (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2005 | Yes | No | |
| Other publications | publication with some data on the Flec-SL trial: | 01/11/2007 | Yes | No | |
| Results article | results | 21/07/2012 | Yes | No | |
| Results article | results | 18/09/2012 | Yes | No | |
| Results article | results | 09/10/2013 | Yes | No |
