BAXDROSTAT for Heart failure | Type 2 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent\n- Diagnosed with T2DM and requiring treatment\n- Established CV disease ((ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)\n- Documented history of HTN (diagnosed and/or treated) and an SBP ≥ 130 mmHg (either the most recent value within 4 weeks of screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.\n- Local laboratory serum or plasma potassium must meet the following criteria at the Screening Visit, based on screening eGFR: o for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit o for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit\n- At least one additional risk factor for HF : o Age ≥ 70 years o UACR > 20 mg/g o eGFR < 60 mL/min/1.73 m2 o History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease) o History of atrial fibrillation or atrial flutter o NT-proBNP > 125 ng/L\n- All WOCBP must have a negative pregnancy test result at screening, and not be at stage of breastfeeding."}

Exclusion criteria

• {"criterion_text":"- Previously confirmed diagnosis and treatment of chronic symptomatic heart failure (Heart failure stages C and D by the ACC/AHA classification)\n- An eGFR < 30 mL/min/1.73 m2 at screening\n- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening\n- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c >10.5% (> 91 mmol/mol) at screening\n- Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment\n- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation.\n- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation.\n- Percutaneous coronary intervention or Transcatheter Aortic Valve Replacement within 1 month prior to randomisation.\n- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.\n- History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients).\n- History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n- Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior to screening and/or during the study.\n- Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening\n- Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening\n- To exclude participants with hereditary galactose intolerance, lactase deficiency, or glucose/galactose malabsorption.\n- Any dialysis (including for acute kidney injury) within 3 months prior to screening\n- Any acute kidney injury within 3 months prior to screening."}

Primary endpoints

• {"endpoint_text":"- Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation • CV death","definition_or_measurement_approach":"Time-to-event composite endpoint: time to first occurrence of any component of the composite (hospitalisation for heart failure, heart failure without hospitalisation, or cardiovascular death)."}

Secondary endpoints

• {"endpoint_text":"- Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • CV death","definition_or_measurement_approach":"Time-to-event: time to first occurrence of either hospitalisation for heart failure or cardiovascular death."}
• {"endpoint_text":"- Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation","definition_or_measurement_approach":"Time-to-event: time to first occurrence of either hospitalisation for heart failure or heart failure without hospitalisation."}
• {"endpoint_text":"- Time to first occurrence of any of the components of the composite of: • CV death • MI • Stroke • Hospitalisation for HF","definition_or_measurement_approach":"Time-to-event: time to first occurrence of any component of 4‑point MACE (cardiovascular death, myocardial infarction, stroke, hospitalisation for heart failure)."}
• {"endpoint_text":"- Time to CV death","definition_or_measurement_approach":"Time-to-event: time from randomisation to cardiovascular death."}
• {"endpoint_text":"- Time to all-cause death","definition_or_measurement_approach":"Time-to-event: time from randomisation to death from any cause."}

Methods

• Site-based recruitment using posters and pamphlets at participating centres (posters, pamphlets identified in recruitment materials).
• Patient-facing study guides / patient information leaflets distributed to potential participants.
• Digital recruitment: social media posts (Facebook, Instagram) and website materials.
• Vendor recruitment platforms (e.g., Link2Trials referenced in recruitment material).
• Local invitation letters and e‑communications (e-boks / local patient letters) and site-specific advertisement materials.
• Cohort initiative / call script recruitment (direct contact by phone as part of cohort initiatives).

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden