Clinical Trial: Flecainide-Short Long Study (Flec-SL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.

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.

Detailed Summary:

Details of the trial are described in a design paper published in the American Heart Journal (1).

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with approximately one million affected patients in Germany. Current estimates suggest that the life-time risk for AF is 30% for men and slightly less for women at the age of 40 years. Due to demographic changes in the German population, the incidence and prevalence of AF is expected to double within the next 30 years. AF almost doubles mortality and causes important morbidity, mainly due to thrombo-embolic complications and stroke. In addition, the arrhythmia in itself reduces the chronotropic adaptation of the heart to increased work load and reduces cardiac output, especially in patients with heart failure or other cardiac disease. Restoration of sinus rhythm would reduce this burden of disease.

Acute termination of AF is almost always successful by external electrical cardioversion, especially using recently optimized techniques [biphasic shock wave forms, anterior-posterior electrode position, sintered steel electrode paddles. Maintaining sinus rhythm, however, is a more difficult task. Antiarrhythmic, ion channel-blocking drugs are effective in preventing a part of recurrent episodes of AF. Their long-term use, however, is limited by pro-arrhythmic side effects which are especially apparent during long-term therapy. AF initiates major changes in atrial electrophysiology per se which have been summarized as "electrical remodeling". The main consequence of these changes is a shortening of the atrial refractory period and action potential duration. Electrical remodeling maintains AF and is related to recurrence of AF after successful cardioversion. Electrical remodeling is reversed when sinus rhythm is maintained over approximately 4 weeks af
Sponsor: German Atrial Fibrillation Network

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

Original Primary Outcome: time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holte ECg recording

Current Secondary Outcome:

  • time to first symptomatic episode of AF [ Time Frame: end of trial ]
  • AF burden (number and duration of AF episodes) [ Time Frame: end of trial ]
  • number of hospitalizations due to AF [ Time Frame: end of trial ]
  • time to termination of trial medication [ Time Frame: end of trial ]
  • number of serious adverse events including pro-arrhythmic events [ Time Frame: end of trial ]
  • quality of life [ Time Frame: end of trial ]


Original Secondary Outcome:

  • time to first symptomatic episode of AF
  • AF burden (number and duration of AF episodes)
  • number of hospitalizations due to AF
  • time to termination of trial medication
  • number of serious adverse events including pro-arrhythmic events
  • quality of life


Information By: German Atrial Fibrillation Network

Dates:
Date Received: September 14, 2005
Date Started: March 2005
Date Completion:
Last Updated: September 10, 2012
Last Verified: September 2012