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

Phase 2

Completed

• Conditions: Arrhythmia
• Interventions: Drug: Placebo; Drug: AZD2927

• Registration Number: NCT01396226
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2011-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-09-24
• Results First Submitted QC: 2012-09-24
• Results First Posted: 2012-10-23
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-22
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	A single dose of placebo administered as an iv infusion
1	AZD2927	A single dose of AZD2927 administered as an iv infusion

Primary Outcome Measures

Name	Time	Method
Left Atrial Effective Refractory Period	Baseline to last assessment during IP infusion	Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion

Secondary Outcome Measures

Name	Time	Method
Ventricular Effective Refractory Period	Baseline to last assessment during IP infusion	Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion
Paced QT Interval	Baseline to last assessment during IP infusion	Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
Atrio-ventricular Effective Refractory Period	Baseline to last assessment during IP infusion	Change from observation before IP infusion to during 1st and 2nd LAERP Mean
PA Interval	Baseline to last assessment during IP infusion	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	Baseline to last assessment during IP infusion	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	Baseline to last assessment during IP infusion	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	Baseline to last assessment during IP infusion	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	Baseline to last assessment during IP infusion	Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
RR Interval	Baseline to last assessment during IP infusion	Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion

Trial Locations

Locations (1)

Research Site; 🇸🇪 Örebro, Sweden