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Flecainide-Short Long Study (Flec-SL)

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ClinicalTrials.gov Identifier: NCT00215774
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 11, 2012
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Meda Pharmaceuticals
German Research Foundation
Information provided by (Responsible Party):
Paulus Kirchhof, German Atrial Fibrillation Network

Brief Summary:
A randomized trial to test the hypothesis that short-term pharmacological reversal of electrical remodeling after cardioversion is equally efficient to prevent recurrent atrial fibrillation as standard long-term antiarrhythmic therapy.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Flecainide Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.
Study Start Date : March 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No antiarrhythmic treatment
Control group
Experimental: B-Flecainide treatment
4 weeks treatment with flecainide
Drug: Flecainide
Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
Other Name: Flecainide in all its approved oral preparations
Experimental: C-Flecainide treatment
6 months flecainide treatment
Drug: Flecainide
Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
Other Name: Flecainide in all its approved oral preparations



Primary Outcome Measures :
  1. time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holter ECG recording [ Time Frame: primary endpoint ]

Secondary Outcome Measures :
  1. time to first symptomatic episode of AF [ Time Frame: end of trial ]
  2. AF burden (number and duration of AF episodes) [ Time Frame: end of trial ]
  3. number of hospitalizations due to AF [ Time Frame: end of trial ]
  4. time to termination of trial medication [ Time Frame: end of trial ]
  5. number of serious adverse events including pro-arrhythmic events [ Time Frame: end of trial ]
  6. quality of life [ Time Frame: end of trial ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Documented persistent atrial fibrillation
  • Age of 18 years
  • Documented oral anticoagulation (INR ≥ 2) for at least three weeks prior to inclusion, or exclusion of left atrial thrombi by trans-esophageal echocardiography
  • Written informed consent of the patient

Exclusion Criteria:

  • Current therapy with antiarrhythmic agents of class I and class III other than study medication flecainide. Such antiarrhythmic treatment must be stopped five half lives prior to enrollment. Five half lives correspond to 48 hours for almost all antiarrhythmic agents. For details regarding a specific agent, this information can be obtained through the internet at www.rote-liste.de or from the Fachinformation of the specific compound.
  • Long-term therapy with amiodarone within the last 6 months prior to inclusion
  • Symptomatic bradycardia or symptomatic sick sinus syndrome unless treated with a permanent pacemaker
  • Symptomatic higher degree AV nodal block (grade II or III) unless treated with a permanent pacemaker
  • Brugada syndrome
  • Typical angina pectoris symptoms at rest or during exercise
  • Known untreated coronary artery disease with high-degree coronary stenosis (> 80% reduction in luminal diameter)
  • Myocardial infarction within the last 3 months
  • Left ventricular ejection fraction of more than 40%
  • Creatinine clearance < 50 ml/min*1.73 m2 as determined by the Cockroft-Gould formula. The digital data management system will calculate this value for you during the inclusion process. For completeness of documentation, the formula is given below:
  • Men: Creatinine clearance (ml/min) = (140 - age(years)) * body weight (kg) / (72 * serum creatinine level (mg/dl))
  • Women: Value for men * 0,85
  • Manifest hepatic insufficiency
  • Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
  • Females who are pregnant or breast feeding
  • Females of childbearing potential who are not using a scientifically accepted method of contraception
  • Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
  • Drug addiction or chronic alcohol abuse
  • Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
  • Evidence of an uncooperative attitude
  • Prolongation of the QRS complex by more than 25% during flecainide treatment (measured as the difference in QRS duration between the baseline ECG and the ECG at cardioversion (34))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215774


Sponsors and Collaborators
Atrial Fibrillation Network
German Federal Ministry of Education and Research
Meda Pharmaceuticals
German Research Foundation
Investigators
Principal Investigator: P Kirchhof, Prof AFNET, Kompetenznetz Vorhofflimmern
Principal Investigator: G Breithardt, Prof AFNET, Kompetenznetz Vorhofflimmern

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulus Kirchhof, Prof MD, German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00215774     History of Changes
Other Study ID Numbers: AFNET-B11
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Paulus Kirchhof, German Atrial Fibrillation Network:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action