Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

Phase 2CompletedNCT00748982

AstraZeneca16 enrolled

Overview

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Left Ventricle Function

Interventions

AZD1305DRUG

iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

PlaceboDRUG

iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Gothenburg, Sweden

Outcomes

Primary Outcomes

Left Ventricular Ejection Fraction (LVEF), Change From Baseline

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.

Time frame: 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 Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: Up to 24 hours following start of IV dosing.

Data from ClinicalTrials.gov

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