Back to resultsCardiac Electrophysiological Study
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1305
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
Absolute change, after - before infusion
Secondary Outcome Measures
RAERP (Right Atrial Effective Refractory Period)
Absolute change, after - before infusion
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
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
Cmax Observed for AZD1305
A total of 13 scheduled PK samples for each patient 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
Number of Patients Who Had at Least One AE
Number of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00616629
Brief Title
Cardiac Electrophysiological Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD1305
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
Description
Absolute change, after - before infusion
Time Frame
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 Measure Information:
Title
RAERP (Right Atrial Effective Refractory Period)
Description
Absolute change, after - before infusion
Time Frame
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
Title
VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)
Description
Absolute change, after - before infusion
Time Frame
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
Title
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)
Description
Absolute change, after - before infusion
Time Frame
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
Title
Cmax Observed for AZD1305
Description
A total of 13 scheduled PK samples for each patient during and after infusion
Time Frame
During and after infusion
Title
AUC Total of AZD1305 (Umol*h/L)
Description
A total of 13 scheduled PK samples for each patient during and after infusion
Time Frame
Based on PK samples during and after infusion
Title
Number of Patients Who Had at Least One AE
Description
Number of patients
Time Frame
During active treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauri Toivonen, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Arhus
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
København
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Gŏteborg
Country
Sweden
Facility Name
Research Site
City
Linkŏping
Country
Sweden
Facility Name
Research Site
City
Umea
Country
Sweden
Facility Name
Research Site
City
Ŏrebro
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Cardiac Electrophysiological Study
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