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

Purpose

Medical Products Agency

Condition	Intervention	Phase
Arrhythmia	Drug: AZD2927 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Left Atrial Effective Refractory Period [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion

Secondary Outcome Measures:

Ventricular Effective Refractory Period [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion
Paced QT Interval [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
Atrio-ventricular Effective Refractory Period [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change from observation before IP infusion to during 1st and 2nd LAERP Mean
PA Interval [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
RR Interval [ Time Frame: Baseline to last assessment during IP infusion ] [ Designated as safety issue: No ]
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion

Enrollment:	20
Study Start Date:	September 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 A single dose of AZD2927 administered as an iv infusion	Drug: AZD2927 A single dose of AZD2927 administered as an iv infusion
Placebo Comparator: 2 A single dose of placebo administered as an iv infusion	Drug: Placebo A single dose of placebo administered as an iv infusion

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396226

Locations

Norway
Research Site
Oslo, Norway
Sweden
Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden
Research Site
Örebro, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Stefan C Carlsson, MD, PHD	AstraZeneca
Principal Investigator:	Hakan Walfridsson, MD, PHD	University Hospital Linkoping Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01396226 History of Changes
Other Study ID Numbers:	D4120C00002, 2011-001716-59
Study First Received:	July 13, 2011
Results First Received:	September 24, 2012
Last Updated:	November 22, 2012
Health Authority:	Norway: Norwegian Medicines Agency Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Atrial refractoriness
cardiac electrophysiology
IKACh

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013