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Vernakalant Versus Flecainide: Atrial Contractility

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Vernakalant
Flecainide
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Vernakalant, Flecainide, Echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flecainide

Vernakalant

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Conversion to sinus rhythm
Heart rhythm will be assessed on monitor and confirmed on ECG.
Recurrence of AF
Heart rhythm will be assessed by ECG.

Full Information

First Posted
July 9, 2012
Last Updated
July 18, 2012
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01646281
Brief Title
Vernakalant Versus Flecainide: Atrial Contractility
Official Title
Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Vernakalant, Flecainide, Echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flecainide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vernakalant
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vernakalant
Other Intervention Name(s)
Brinavess, EV product code SUB30707
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Flecainide
Other Intervention Name(s)
Tambocor, EV product code SUB13894MIG
Intervention Description
10-minute infusion of 2 mg/kg (maximal 150 mg)
Primary Outcome Measure Information:
Title
Atrial contractility measured by echocardiography
Description
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).
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.
Secondary Outcome Measure Information:
Title
Conversion to sinus rhythm
Description
Heart rhythm will be assessed on monitor and confirmed on ECG.
Time Frame
Within one hour after drug administration
Title
Recurrence of AF
Description
Heart rhythm will be assessed by ECG.
Time Frame
At one month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ione Limantoro, MD
Phone
+31433875119
Email
ione.limantoro@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Harry Crijns, MD, PhD
Phone
+31433875093
Email
hjgm.crijns@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Crijns, MD, PhD
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Hospital
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ione Limantoro, MD
Phone
+31433875119
Email
ione.limantoro@mumc.nl
First Name & Middle Initial & Last Name & Degree
Harry Crijns, MD, PhD
Phone
+31433875093
Email
hjmg.crijns@mumc.nl
First Name & Middle Initial & Last Name & Degree
Harry Crijns, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ione Limantoro, MD

12. IPD Sharing Statement

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Vernakalant Versus Flecainide: Atrial Contractility

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