Heart Failure and Impaired Kidney Function
Conditions
Interventions
Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:
1. balcinrenone/dapagliflozin 15
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Documented diagnosis of symptomatic HF (NYHA functional class II-IV) 3. Having had a recent HF event within 6 months (hospitalization or urgent visit) 4. Have a LVEF value from an assessment within the last 12 months 5. Managed with SoC therapy for HF and renal impairment according to local guidelines 6. NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter) 7. Not taking an MRA 8. An eGFR >= 20 to < 60 mL/min/1.73 m2 9. Serum/plasma potassium <= 5.0 mmol/L
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period 2. Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations 3. History of hypertrophic obstructive cardiomyopathy 4. Complex congenital heart disease or severe uncorrected primary valvular disease 5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker 6. Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours 7. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of CO PD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment 8. Type 1 diabetes mellitus 9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy 10. Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy 11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks 12. Treatment with strong or moderate CYP3A4 inhibitor or inducer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of any of the components of the composite of: - CV death - HF hospitalisation - HF event without hospitalisation | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Philippines, South Africa, South Korea, Taiwan, Thailand, Turkey, United States, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed