Resumen del Estudio
La insuficiencia cardíaca y la obesidad son condiciones que frecuentemente van de la mano, complicando la salud del paciente y aumentando el riesgo de hospitalización. Este ensayo clínico de Fase 3 evalúa el uso de Maridebart Cafraglutide (también conocido como MariTide o AMG 133), un medicamento innovador que actúa sobre el metabolismo, para ver si puede mejorar el pronóstico de pacientes que padecen insuficiencia cardíaca y tienen un índice de masa corporal alto. El objetivo principal es determinar si, al añadir este medicamento inyectable al tratamiento estándar, se logran reducir los eventos graves como las hospitalizaciones por fallas cardíacas, las visitas de urgencia y la mortalidad cardiovascular. Además, se busca evaluar si los pacientes experimentan una mejoría notable en sus síntomas y calidad de vida. Es una oportunidad para acceder a una terapia avanzada enfocada en el eje corazón-metabolismo.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar adultos (mayores de 18 años) con obesidad (IMC ≥ 30) y diagnóstico confirmado de insuficiencia cardíaca con fracción de eyección >40% y síntomas activos. No pueden participar pacientes con Diabetes Tipo 1, enfermedad renal severa, antecedentes recientes de infarto o accidente cerebrovascular, o historia de cáncer medular de tiroides.
- Age ≥ 18 years at the time of informed consent.
- BMI ≥ 30.0 kg/m\^2 at the time of randomization.
- HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
- Managed with HF standard of care therapies.
- Left ventricular ejection fraction (LVEF) of \> 40% within 12 months from the beginning of screening.
- Elevated NT-proBNP.
- Participants must have at least one of the following:
- History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
- HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
- Any lifetime history of LVEF ≤ 40%.
- Hospitalized with acute decompensated HF at the time of or during the screening period.
- Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
- For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
- SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \> 160 mmHg during the screening period.
- History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
- Any personal lifetime history of, or family history(first-degree relative\[s\]) of medullary thyroid carcinoma or MEN-2.
- eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
- Calcitonin ≥ 50 ng/L (pg/mL) at screening.
- Acute or chronic hepatitis.
- Any of the following psychiatric history:
- History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
- Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.