Cardiac Electrophysiological Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00616629

Purpose

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

Condition	Intervention	Phase
Atrial Flutter	Drug: AZD1305	Phase I Phase II

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Pharmacodynamics 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assessment of atrial effective refractory period during intravenous infusion [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of other cardiac electrophysiological properties, haemodynamics, and electrocardiographic variables during intravenous infusion [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Intravenous infusion

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616629

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Lauri Toivonen, MD

Helsinki University Hospital

More Information

Responsible Party:	AstraZeneca ( AstraZeneca AZD1305 Medical Science Director )
Study ID Numbers:	D3190C00005, 2007-0003455-36 (EudraCT No)
Study First Received:	February 5, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00616629
Health Authority:	Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines

Study placed in the following topic categories:

Heart Diseases
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009