Vernakalant Versus Flecainide: Atrial Contractility

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01646281
• Other study ID #: NL39854.068.12
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 9, 2012
• Last updated: July 18, 2012
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2012
• Source: Maastricht University Medical Center
• Contact: Ione Limantoro, MD
• Phone: +31433875119
• Email: ione.limantoro[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Vernakalant
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
10-minute infusion of 2 mg/kg (maximal 150 mg)

Locations

Country	Name	City	State
Netherlands	Maastricht University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial contractility measured by echocardiography	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).	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.	No
Secondary	Conversion to sinus rhythm	Heart rhythm will be assessed on monitor and confirmed on ECG.	Within one hour after drug administration	No
Secondary	Recurrence of AF	Heart rhythm will be assessed by ECG.	At one month follow-up	No