A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients

Arrhythmia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396226
• Other study ID #: D4120C00002
• Secondary ID: 2011-001716-59
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: November 22, 2012
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Medical Products Agency

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• AZD2927
A single dose of AZD2927 administered as an iv infusion
• Placebo
A single dose of placebo administered as an iv infusion

Locations

Country	Name	City	State
Norway	Research Site	Oslo
Sweden	Research Site	Linköping
Sweden	Research Site	Örebro
Sweden	Research Site	Stockholm
Sweden	Research Site	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Atrial Effective Refractory Period	Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion	Baseline to last assessment during IP infusion	No
Secondary	Ventricular Effective Refractory Period	Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion	Baseline to last assessment during IP infusion	No
Secondary	Paced QT Interval	Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements	Baseline to last assessment during IP infusion	No
Secondary	Atrio-ventricular Effective Refractory Period	Change from observation before IP infusion to during 1st and 2nd LAERP Mean	Baseline to last assessment during IP infusion	No
Secondary	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	Baseline to last assessment during IP infusion	No
Secondary	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.	Baseline to last assessment during IP infusion	No
Secondary	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.	Baseline to last assessment during IP infusion	No
Secondary	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	Baseline to last assessment during IP infusion	No
Secondary	QRS Duration	Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion	Baseline to last assessment during IP infusion	No
Secondary	RR Interval	Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion	Baseline to last assessment during IP infusion	No