Cardiac Electrophysiological Study

Phase 2

Completed

• Conditions: Atrial Flutter

• Registration Number: NCT00616629
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-15
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-01-24
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Results First Posted: 2011-09-22
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))	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	Absolute change, after - before infusion

Secondary Outcome Measures

Name	Time	Method
RAERP (Right Atrial Effective Refractory Period)	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	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)	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	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)	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	Absolute change, after - before infusion
Cmax Observed for AZD1305	During and after infusion	A total of 13 scheduled PK samples for each patient during and after infusion
AUC Total of AZD1305 (Umol*h/L)	Based on PK samples during and after infusion	A total of 13 scheduled PK samples for each patient during and after infusion
Number of Patients Who Had at Least One AE	During active treatment period	Number of patients

Trial Locations

Locations (1)

Research Site; 🇸🇪 Ŏrebro, Sweden