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Completed

NCT Number: NCT00616629

Cardiac Electrophysiological Study

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

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1305

Drug

Intravenous infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 15, 2008
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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