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Vernakalant Versus Flecainide: Atrial Contractility

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ClinicalTrials.gov Identifier: NCT01646281
Recruitment Status : Unknown
Verified July 2012 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vernakalant Drug: Flecainide Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Flecainide
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.
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.
Other Name: Brinavess, EV product code SUB30707


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    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 Outcome Measures :
  1. Conversion to sinus rhythm [ Time Frame: Within one hour after drug administration ]
    Heart rhythm will be assessed on monitor and confirmed on ECG.

  2. Recurrence of AF [ Time Frame: At one month follow-up ]
    Heart rhythm will be assessed by ECG.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646281


Contacts
Contact: Ione Limantoro, MD +31433875119 ione.limantoro@mumc.nl
Contact: Harry Crijns, MD, PhD +31433875093 hjgm.crijns@mumc.nl

Locations
Netherlands
Maastricht University Hospital Not yet recruiting
Maastricht, Netherlands, 6229 HX
Contact: Ione Limantoro, MD    +31433875119    ione.limantoro@mumc.nl   
Contact: Harry Crijns, MD, PhD    +31433875093    hjmg.crijns@mumc.nl   
Principal Investigator: Harry Crijns, MD, PhD         
Sub-Investigator: Ione Limantoro, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Harry Crijns, MD, PhD Maastricht University Hospital
More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01646281     History of Changes
Other Study ID Numbers: NL39854.068.12
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by Maastricht University Medical Center:
Atrial fibrillation
Vernakalant
Flecainide
Echocardiography

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action