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Cardiac Electrophysiological Study

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ClinicalTrials.gov Identifier: NCT00616629
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : September 22, 2011
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Atrial Flutter Drug: AZD1305 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Intervention Details:
  • Drug: AZD1305
    Intravenous infusion


Primary Outcome Measures :
  1. LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) [ 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 ]
    Absolute change, after - before infusion


Secondary Outcome Measures :
  1. RAERP (Right Atrial Effective Refractory Period) [ 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 ]
    Absolute change, after - before infusion

  2. VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) [ 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 ]
    Absolute change, after - before infusion

  3. 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) [ 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 ]
    Absolute change, after - before infusion

  4. Cmax Observed for AZD1305 [ Time Frame: During and after infusion ]
    A total of 13 scheduled PK samples for each patient during and after infusion

  5. AUC Total of AZD1305 (Umol*h/L) [ Time Frame: Based on PK samples during and after infusion ]
    A total of 13 scheduled PK samples for each patient during and after infusion

  6. Number of Patients Who Had at Least One AE [ Time Frame: During active treatment period ]
    Number of patients



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616629


Locations
Denmark
Research Site
Aalborg, Denmark
Research Site
Arhus, Denmark
Research Site
Hellerup, Denmark
Research Site
København, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Kuopio, Finland
Research Site
Oulu, Finland
Norway
Research Site
Bergen, Norway
Research Site
Oslo, Norway
Sweden
Research Site
Gŏteborg, Sweden
Research Site
Linkŏping, Sweden
Research Site
Umea, Sweden
Research Site
Ŏrebro, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lauri Toivonen, MD Helsinki University Central Hospital

Responsible Party: AstraZeneca AZD1305 Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00616629     History of Changes
Other Study ID Numbers: D3190C00005
2007-0003455-36 (EudraCT No)
First Posted: February 15, 2008    Key Record Dates
Results First Posted: September 22, 2011
Last Update Posted: September 22, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes