Vernakalant Versus Flecainide: Atrial Contractility
This study is not yet open for participant recruitment.
Verified July 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
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
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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
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 May 19, 2013