BALCINRENONE, DAPAGLIFLOZIN for Heart failure | Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- 1. Age ≥ 18 years\n- 2. Documented diagnosis of symptomatic HF (NYHA functional class II-IV)\n- 3. Having had a recent HF event within 6 months (hospitalization or urgent visit)\n- 4. Have a LVEF value from an assessment within the last 12 months\n- 5. Managed with SoC therapy for HF and renal impairment according to local guidelines\n- 6. NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)\n- 7. Not taking an MRA\n- 8. An eGFR ≥ 20 to < 60 mL/min/1.73 m2\n- 9. Serum/plasma potassium ≤ 5.0 mmol/L"}

Exclusion criteria

• {"criterion_text":"- 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\n- 8. Type 1 diabetes mellitus\n- 9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy\n- 12. Treatment with strong or moderate CYP3A4 inhibitor or inducer\n- 10. Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy\n- 11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks\n- 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 planned to undergo any of these operations\n- 3. History of hypertrophic obstructive cardiomyopathy\n- 4. Complex congenital heart disease or severe uncorrected primary valvular disease\n- 5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker\n- 6. Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours\n- 7. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment"}

Primary endpoints

• {"endpoint_text":"- Time to first occurrence of any of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation","definition_or_measurement_approach":"Time‑to‑event analysis: time from randomisation to first occurrence of any component of the composite (CV death, HF hospitalisation, HF event without hospitalisation)."}

Secondary endpoints

• {"endpoint_text":"- 1. Total occurrences (first and recurrent) of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation\n- 2. Total occurrences (first and recurrent) of HF hospitalisations\n- 3. Time to CV death\n- 4. The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation\n- 5.Time to death from any cause","definition_or_measurement_approach":"Secondary endpoints include counts of first and recurrent events for composite components and HF hospitalisations, time‑to‑event for CV death and all‑cause death, and a hierarchical composite including change from baseline in KCCQ total symptom score at 24 weeks."}

Methods

• Posters (site/poster recruitment materials listed in recruitment documents)
• Pamphlets/leaflets (patient recruitment pamphlets listed per country)
• Social media ads and landing pages (social media landing page, Facebook/Instagram ad materials listed)
• Newspaper advertisements (country recruitment materials include newspaper ads)
• Local patient letters / local outreach (local patient letter documents listed)

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden