Flecainide-Short Long Study (Flec-SL)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00215774
First received: September 14, 2005
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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 Intervention
Atrial Fibrillation
Drug: Flecainide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

Primary Outcome Measures:
  • time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holter ECG recording [ Time Frame: primary endpoint ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to first symptomatic episode of AF [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
  • AF burden (number and duration of AF episodes) [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
  • number of hospitalizations due to AF [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
  • time to termination of trial medication [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
  • number of serious adverse events including pro-arrhythmic events [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: end of trial ] [ Designated as safety issue: No ]

Enrollment: 760
Study Start Date: March 2005
Study Completion Date: March 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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))
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215774

Sponsors and Collaborators
German 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
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: September 14, 2005
Last Updated: September 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:
Atrial fibrillation

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

ClinicalTrials.gov processed this record on September 30, 2014