Clinical trial NCT00616629: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Flutter
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
timeFrame: 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 outcomes:
measure: RAERP (Right Atrial Effective Refractory Period)
timeFrame: 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
measure: VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Cmax Observed for AZD1305
timeFrame: During and after infusion
measure: AUC Total of AZD1305 (Umol*h/L)
timeFrame: Based on PK samples during and after infusion
measure: Number of Patients Who Had at Least One AE
timeFrame: During active treatment period
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Arhus
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: København
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Gŏteborg
country: Sweden
facility: Research Site
city: Linkŏping
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Ŏrebro
country: Sweden
facility: Research Site
Study officials:
affiliation: Helsinki University Central Hospital
name: Lauri Toivonen, MD
role: PRINCIPAL_INVESTIGATOR
References: