Last updated 50 days ago
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
11300 patients around the world
Available in Argentina
AstraZeneca
11300Patients around the world
This study is for people with
Heart failure
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.Diagnosed with T2DM and requiring treatment.Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease).History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.Central laboratory serum potassium ≥ 3.0 to ≤ 4.8 mmol/L at screening.At least one additional risk factor for HF.Age ≥ 70 years.UACR > 20 mg/g.eGFR < 60 mL/min/1.73 m2.History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease).History of atrial fibrillation or atrial flutter.NT-proBNP > 125 ng/L.
- Established heart failure diagnosis.An eGFR < 30 mL/min/1.73 m2 at screening.Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening.Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening.Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment.Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation.Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation.Percutaneous coronary intervention within 1 month prior to randomisation.Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.Documented history of adrenal insufficiency.Any dialysis (including for acute kidney injury) within 3 months prior to screening.Any acute kidney injury within 3 months prior to screening.History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients).History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to screening).Drug or alcohol abuse that in the Investigator's judgement makes the participant a poor candidate for the study.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.Concomitant therapy with strong inducers of cytochrome P450.Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening.Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.
StudyPrevent-HF
SponsorAstraZeneca
Conditions
Heart failure
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06677060
