Left ventricular function in patient with left ventricular dysfunction.
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male patients and postmenopausal women aged 20-80 years 3. LVEF 30- 45% on echocardiography.Patients with an ejection fraction >45% can be included if he/she has a well documented diagnosis of cardiac failure/cardiomyopathy with a previous EF below 45% and is judged to have normal ejection fraction due to optimised medical treatment. 4. In SR without diagnosis of AF during the dosing days. 5. No significant changes in the medication for heart failure, during the preceding 1 month before enrolment (e.g. ACE inhibitors, AT1 blockers, beta-receptor blockers and/or aldosterone antagonists, diuretics) as judged by the investigator 6. deleted 7. Provision of written informed consent for genetic research (optional). 1. Women will be considered postmenopausal if they fulfil criterion a) and/or b), and criterion c): a) Natural menopause with last menstruation >1 year ago b) Induced menopause with last menstruation >1 year ago, due to: - Bilateral oophorectomy and/or hysterectomy - Radiation induced oophorectomy - Chemotherapy induced menopause c) Serum FSH, LH and/or plasma oestradiol levels in the postmenopausal range as defined by the laboratory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically significant deviation in physical findings or laboratory values as judged by the investigator 2. Severe or clinically unstable heart failure (NYHA III-IV) 3. Haemodynamically unstable condition as judged by the investigator, systolic blood pressure (BP) 180 mmHg, or diastolic BP >105 mmHg at enrolment 4. AV-block I (prolonged PQ (PR) interval defined as >220 ms), AV-block II, AV-block III, bundle branch block (BBB) 5. QRS duration >120 ms at randomization 6. QTcF interval >450 ms measured at randomization 7. Any of the following events, or any other significant cardiovascular event as judged by the investigator, during the last 3 months before randomisation: myocardial infarction, unstable angina pectoris or other signs of myocardial ischaemia, stroke or transient ischaemic attack (TIA), myocardial revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)) 8. Significant clinical illness or surgical procedure within 4 weeks preceding the pre-entry visit 9. Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome 10. History of past or ongoing severe allergic disease, significant mental, renal or hepatic disorder, or other significant disease as judged by the investigator 11. Known preexcitation 12. History and/or signs of clinically significant sinus node dysfunction, or sinus rhythm with a heart rate (HR) below 45 or above 100 beats per minute 13. Pacemaker or Implantable Cardioverter Defibrillator (ICD) therapy 14. Significant aortic stenosis or hypertrophic obstructive cardiomyopathy 15. C-Reactive Protein (CRP) >15 mg/L 16. Potassium in serum or plasma below 3.8 or above 5.3 mmol/L 17. Blood Haemoglobin (Hb) 7 cigarettes or snuff portions per week) 26. Blood or plasma donation within the preceding 12 weeks before the administration of AZD1305 or other investigational product 27. Intake of an investigational drug within the preceding 3 months before the first administration of AZD1305 28. Intake of AZD7009 (predecessor of AZD1305) and/or AZD130
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore if AZD1305 compromises left ventricular function in patients with left ventricular dysfunction.;Secondary Objective: To evaluate the tolerability and safety of AZD1305 given as an intravenous (iv) infusion to patients with left ventricular dysfunction. To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction. To exploratively evaluate the relationship between dose, plasma concentration and QTcF interval, QRS duration and, if possible, left ventricular function. To collect and store DNA samples (from all randomised patients who give additional informed consent) for potential future exploratory research into genes which may influence drug response of AZD1305. ;Primary end point(s): | — |
Countries
Sweden
Outcome results
None listed