Phase
Condition
Chest Pain
Congestive Heart Failure
Nephropathy
Treatment
Placebo
AZD5462
Dapagliflozin
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a pre-existing diagnosis of heart failure (HF).
Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based onechocardiography taken within the last 9 months.
Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) atScreening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
Participants must be on stable HF standard of care (SoC) medication for at least 4weeks prior to Screening. If the participant is currently taking diuretics, thendiuretics must also be stable for at least one week prior to Screening.
Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2)inhibitor treatment for at least 12 weeks prior to Screening.
Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening.
Exclusion
Exclusion Criteria:
Historical or current evidence of a clinically significant disease or disorder.
Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any ofthe excipients of these drug products.
Congenital long QT syndrome or history of QT prolongation associated with othermedications that required discontinuation of that medication.
Cardiac ventricular arrhythmia that requires treatment. However, participants withatrial fibrillation or flutter and controlled ventricular rate (eg, resting heartrate < 110 beats per minute) are permitted. Participants with cardiac ventriculararrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and arestable are permitted.
History of or anticipated heart transplant.
Any planned highly invasive cardiovascular procedure (eg, coronaryrevascularisation, valve repair/replacement, aortic aneurysm surgery).
Any evidence of clinically important disease or disorder which in the Investigator'sopinion makes it undesirable for the participant to participate in the study.
Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis Bvirus core antibody at Screening.
Study Design
Study Description
Connect with a study center
Research Site
Sofia, 1612
BulgariaSite Not Available
Research Site
Sofia 727011, 1612
BulgariaSite Not Available
Research Site
Mölndal, SE-431 53
SwedenSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.