Vernakalant Versus Flecainide: Atrial Contractility

NCT01646281 | Unknown Phase 4 DMC

• 1 other identifier: NL39854.068.12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Vernakalant; Flecainide; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Conversion to sinus rhythm

  Within one hour after drug administration

• Recurrence of AF

  At one month follow-up

Study Arms (2)

Flecainide

ACTIVE COMPARATOR

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.

Drug: Flecainide

Vernakalant

ACTIVE COMPARATOR

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.

Drug: Vernakalant

Interventions

Vernakalant DRUG

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.

Also known as: Brinavess, EV product code SUB30707

Vernakalant

Flecainide DRUG

10-minute infusion of 2 mg/kg (maximal 150 mg)

Also known as: Tambocor, EV product code SUB13894MIG

Flecainide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Hospital

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

vernakalant; Flecainide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Harry Crijns, MD, PhD

  Maastricht University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ione Limantoro, MD

CONTACT

+31433875119; ione.limantoro@mumc.nl

Harry Crijns, MD, PhD

CONTACT

+31433875093; hjgm.crijns@mumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 20, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

NL (1)