Cardiac Electrophysiological Study

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure

The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Drug: AZD1305

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Research Site
  • Arhus, Denmark
    • Research Site
  • Hellerup, Denmark
    • Research Site
  • København, Denmark
    • Research Site
• Finland
  • Helsinki, Finland
    • Research Site
  • Kuopio, Finland
    • Research Site
  • Oulu, Finland
    • Research Site
• Norway
  • Bergen, Norway
    • Research Site
  • Oslo, Norway
    • Research Site
• Sweden
  • Gŏteborg, Sweden
    • Research Site
  • Linkŏping, Sweden
    • Research Site
  • Umea, Sweden
    • Research Site
  • Ŏrebro, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation
• Sinus rhythm at randomisation

Exclusion Criteria:

• QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
• Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
• QRS duration >120 ms at randomisation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAERP (Right Atrial Effective Refractory Period)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona
Cmax Observed for AZD1305	A total of 13 scheduled PK samples for each patient during and after infusion	During and after infusion
AUC Total of AZD1305 (Umol*h/L)	A total of 13 scheduled PK samples for each patient during and after infusion	Based on PK samples during and after infusion
Number of Patients Who Had at Least One AE	Number of patients	During active treatment period

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Lauri Toivonen, MD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): September 22, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: D3190C00005; 2007-0003455-36 (EudraCT No)