Back to resultsA Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
Primary Purpose
Arrhythmia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2927
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Arrhythmia focused on measuring Atrial refractoriness, cardiac electrophysiology, IKACh
Eligibility Criteria
Inclusion Criteria:
- male or postmenopausal female, aged 20 to 80 years inclusive,
- clinical indication for catheter ablation of atrial flutter,
- history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
- sinus rhythm at randomisation,
- adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,
Exclusion Criteria:
- cardioversion within 14 days before randomisation,
- history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
- QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,
- history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
- personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
A single dose of AZD2927 administered as an iv infusion
A single dose of placebo administered as an iv infusion
Outcomes
Primary Outcome Measures
Left Atrial Effective Refractory Period
Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion
Secondary Outcome Measures
Ventricular Effective Refractory Period
Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion
Paced QT Interval
Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
Atrio-ventricular Effective Refractory Period
Change from observation before IP infusion to during 1st and 2nd LAERP Mean
PA Interval
Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start
AH Interval
Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.
HV Interval
Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.
PR Interval
Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
QRS Duration
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
RR Interval
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01396226
Brief Title
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
Official Title
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
Medical Products Agency
Detailed Description
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Atrial refractoriness, cardiac electrophysiology, IKACh
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
A single dose of AZD2927 administered as an iv infusion
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo administered as an iv infusion
Intervention Type
Drug
Intervention Name(s)
AZD2927
Intervention Description
A single dose of AZD2927 administered as an iv infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single dose of placebo administered as an iv infusion
Primary Outcome Measure Information:
Title
Left Atrial Effective Refractory Period
Description
Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion
Time Frame
Baseline to last assessment during IP infusion
Secondary Outcome Measure Information:
Title
Ventricular Effective Refractory Period
Description
Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion
Time Frame
Baseline to last assessment during IP infusion
Title
Paced QT Interval
Description
Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
Time Frame
Baseline to last assessment during IP infusion
Title
Atrio-ventricular Effective Refractory Period
Description
Change from observation before IP infusion to during 1st and 2nd LAERP Mean
Time Frame
Baseline to last assessment during IP infusion
Title
PA Interval
Description
Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start
Time Frame
Baseline to last assessment during IP infusion
Title
AH Interval
Description
Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.
Time Frame
Baseline to last assessment during IP infusion
Title
HV Interval
Description
Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.
Time Frame
Baseline to last assessment during IP infusion
Title
PR Interval
Description
Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Time Frame
Baseline to last assessment during IP infusion
Title
QRS Duration
Description
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Time Frame
Baseline to last assessment during IP infusion
Title
RR Interval
Description
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Time Frame
Baseline to last assessment during IP infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or postmenopausal female, aged 20 to 80 years inclusive,
clinical indication for catheter ablation of atrial flutter,
history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
sinus rhythm at randomisation,
adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,
Exclusion Criteria:
cardioversion within 14 days before randomisation,
history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,
history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan C Carlsson, MD, PHD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hakan Walfridsson, MD, PHD
Organizational Affiliation
University Hospital Linkoping Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Linköping
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Umeå
Country
Sweden
Facility Name
Research Site
City
Örebro
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
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