A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

Exclusion Criteria

• •Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
• •1. Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to consent or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to consent.
• •2. Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy.
• •3. History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency.
• •4. Amyloidosis, Fabry disease, or haemochromatosis.
• •5. Pericardial disease (i.e., visually significant white pericardium on echocardiogram).
• •6. Known coagulation disorders.
• •7. Current diagnosis of active hepatitis.
• •8. Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator.
• •9. Decompensated HF or any cardiopulmonary hospitalisation, except planned hospitalisation without worsening of cardiac or pulmonary functions, within 4 weeks prior to consent or during the Screening period.
• •10. History of active malignancy within 2 years, except for fully excised or treated basal cell carcinoma, or ≤ 2 squamous cell carcinomas of the skin and participants who are under investigation for breast or cervical cancer, including participants with a pap smear of grade ≥ 3.
• •History of hypersensitivity to AZD5462 or any component of AZD5462 drug product.
• •Known history of drug or alcohol abuse within 24 months of Screening.
• •Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
• •Cardiac ventricular arrhythmia that requires treatment.
• •History of or anticipated heart transplant.
• •Current or planned cardiac resynchronization therapy/bi-ventricular pacemaker or mechanical assist device implantation.
• •Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc).
• •Positive hepatitis C antibody, or hepatitis B virus surface antigen at Screening. Participants with positive hepatitis B virus core antibody can be included in the study as long as hepatitis B virus surface antigen is negative, and there are no other signs of an active hepatitis B.
• •Known to have historically tested positive for Human Immunodeficiency Virus.