Vernakalant Versus Flecainide: Atrial Contractility

NCT01646281 — Phase 4, Unknown, 70 participants, Maastricht University Medical Center

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Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation

Registry	NCT01646281
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, diagnostic
Enrollment	70 (Estimated)
Sponsor	Maastricht University Medical Center (Other)
Conditions	Atrial Fibrillation
Interventions	Vernakalant, Flecainide (Drug)
Dates	start 2012-08-01, primary completion 2013-08-01 (estimated), completion 2013-08-01 (estimated), first posted 2012-07-20, last updated 2012-07-20
Locations	1 site in Netherlands

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Flecainide	Active comparator	Drug: 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.
Vernakalant	Active comparator	Drug: 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.

Vernakalant (Drug), also known as Brinavess, EV product code SUB30707: 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.
Flecainide (Drug), also known as Tambocor, EV product code SUB13894MIG: 10-minute infusion of 2 mg/kg (maximal 150 mg)

+Outcome measures

Primary outcomes

Atrial contractility measured by echocardiography [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.]: 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).

Secondary outcomes

Conversion to sinus rhythm [Within one hour after drug administration]: Heart rhythm will be assessed on monitor and confirmed on ECG.
Recurrence of AF [At one month follow-up]: Heart rhythm will be assessed by ECG.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* persistent AF or paroxysmal AF
* eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm
* receiving adequate anticoagulant therapy (or having an episode of AF lasting < 24 hours)

Exclusion Criteria:

* refusal or inability to give informed consent to participate in this study
* atrial flutter
* contra-indications for receiving vernakalant or flecainide according to MUMC+ protocol (unstable hemodynamic condition, LVEF < 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction)
* age < 18 years

+Locations (1)

Facility	City	Country	Status
Maastricht University Hospital	Maastricht	Netherlands

+Investigators

Harry Crijns, MD, PhD, Principal investigator, Maastricht University Hospital

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