Vernakalant Versus Flecainide: Atrial Contractility
Recruitment status was Not yet recruiting
Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation|
- Atrial contractility measured by echocardiography [ Time Frame: After successful cardioversion to sinus rhythm (this can be during infusion of medication or during the first hour after infusion) an echocardiography will be performed within one hour. ] [ Designated as safety issue: No ]Echocardiography will be performed when the patient has sinus rhythm. Transmitral flow will be measured by pulsed Doppler from an apical four chamber view. Peak velocities of the early filling (E) wave and atrial filling (A) will be determined. We will also determine the E/A ratio and the atrial volumes and the total atrial conduction time (PA-TVI).
- Conversion to sinus rhythm [ Time Frame: Within one hour after drug administration ] [ Designated as safety issue: No ]Heart rhythm will be assessed on monitor and confirmed on ECG.
- Recurrence of AF [ Time Frame: At one month follow-up ] [ Designated as safety issue: No ]Heart rhythm will be assessed by ECG.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Flecainide
Patients randomized to flecainide will receive a 10-minute infusion of 2 mg/kg (maximal 150 mg) flecainide. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.
10-minute infusion of 2 mg/kg (maximal 150 mg)
Other Name: Tambocor, EV product code SUB13894MIG
Active Comparator: Vernakalant
Patients randomized to vernakalant will receive a 10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.
10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.
Other Name: Brinavess, EV product code SUB30707
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646281
|Contact: Ione Limantoro, MDfirstname.lastname@example.org|
|Contact: Harry Crijns, MD, PhDemail@example.com|
|Maastricht University Hospital||Not yet recruiting|
|Maastricht, Netherlands, 6229 HX|
|Contact: Ione Limantoro, MD +31433875119 firstname.lastname@example.org|
|Contact: Harry Crijns, MD, PhD +31433875093 email@example.com|
|Principal Investigator: Harry Crijns, MD, PhD|
|Sub-Investigator: Ione Limantoro, MD|
|Principal Investigator:||Harry Crijns, MD, PhD||Maastricht University Hospital|