Vernakalant Versus Flecainide: Atrial Contractility

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01646281
First received: July 9, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Vernakalant
Drug: Flecainide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within one hour after drug administration ] [ Designated as safety issue: No ]
    Heart rhythm will be assessed on monitor and confirmed on ECG.

  • Recurrence of AF [ Time Frame: At one month follow-up ] [ Designated as safety issue: No ]
    Heart rhythm will be assessed by ECG.


Estimated Enrollment: 70
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01646281     History of Changes
Other Study ID Numbers: NL39854.068.12
Study First Received: July 9, 2012
Last Updated: July 18, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014