Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

Study Overview
=================
Brief Summary
-----------------
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction

Official Title
-----------------
A Single-centre, Single-blind, Randomised, Placebo-controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous (iv) Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction

Conditions
-----------------
Left Ventricle Function

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients and postmenopausal women Mildly/moderately decreased heart function Regular heart rhythm Exclusion Criteria: Potassium outside normal reference values Child bearing potential Severely decreased heart function

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1305<br>* iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction (LVEF), Change From Baseline | To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction. | From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group | To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction. | From randomisation to last study visit (mean infusion time 1.6 hours) | 
| Area Under Curve (AUC) ( µmol*h/L) of AZD1305 | To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction | From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. | 
| QTcF Interval | Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula | Up to 24 hours following start of IV dosing. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1305, anti-arrhythmics, safety