Clinical trial NCT01396226: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arrhythmia
Keywords: Atrial refractoriness
cardiac electrophysiology
IKACh
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Left Atrial Effective Refractory Period
timeFrame: Baseline to last assessment during IP infusion
Secondary outcomes:
measure: Ventricular Effective Refractory Period
timeFrame: Baseline to last assessment during IP infusion
measure: Paced QT Interval
timeFrame: Baseline to last assessment during IP infusion
measure: Atrio-ventricular Effective Refractory Period
timeFrame: Baseline to last assessment during IP infusion
measure: PA Interval
timeFrame: Baseline to last assessment during IP infusion
measure: AH Interval
timeFrame: Baseline to last assessment during IP infusion
measure: HV Interval
timeFrame: Baseline to last assessment during IP infusion
measure: PR Interval
timeFrame: Baseline to last assessment during IP infusion
measure: QRS Duration
timeFrame: Baseline to last assessment during IP infusion
measure: RR Interval
timeFrame: Baseline to last assessment during IP infusion
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Stefan C Carlsson, MD, PHD
role: STUDY_DIRECTOR
affiliation: University Hospital Linkoping Sweden
name: Hakan Walfridsson, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: