Resumen del Estudio
Este ensayo clínico de Fase 3 está dirigido a personas mayores de 40 años diagnosticadas con Diabetes Tipo 2 y que presentan antecedentes de hipertensión arterial o enfermedad cardiovascular establecida. El objetivo es evaluar si la combinación del medicamento en investigación Baxdrostat junto con Dapagliflozina es más eficaz que el tratamiento estándar para proteger el corazón. El estudio busca prevenir el desarrollo de insuficiencia cardíaca y reducir el riesgo de muerte por causas cardiovasculares en pacientes de alto riesgo metabólico. Al participar, los pacientes recibirán un seguimiento médico riguroso para monitorear su salud cardíaca, renal y metabólica, contribuyendo al avance de nuevas terapias preventivas.
Criterios de Elegibilidad
Resumen de Elegibilidad:Criterios principales: Hombres y mujeres ≥40 años con Diabetes Tipo 2, enfermedad cardiovascular y presión arterial alta (≥130 mmHg). Deben tener factores de riesgo adicionales como edad avanzada o biomarcadores elevados. NO pueden participar pacientes con diagnóstico previo de insuficiencia cardíaca, Diabetes Tipo 1, insuficiencia renal severa o enfermedad hepática grave (Child-Pugh C).
- 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.
- 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
- Previously confirmed diagnosis and treatment of heart failure
- 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
- Prohibited concomitant medications