LCZ696 in Advanced LV Hypertrophy and HFpEF

Más betegség

• Evidence of myocardial ischemia during stress echocardiography;
• NYHA classification I or decompensated heart failure at screening;
• Significant left sided structural valve disease;
• Secondary hypertension;
• Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;
• Myocardial infarction or myocardial revascularization within the last 3 months of screening;
• Stroke or TIA within the last 3 months of screening;
• Autoimmunic and oncological diseases;

Laborértékek

• Anemia (Hb < 100 g/l);
• Impaired renal function, defined as eGFR < 30 ml/min/1.73 m²;
• Potassium concentration >5.2 mmol/L.

Életkor

• Age ≤ 18 years;

Egyéb

• Chronic atrial flutter or atrial fibrillation;
• Alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.);
• Systolic blood pressure < 110 mmHg or > 180 mmHg;
• Diastolic blood pressure < 40 mmHg or > 100 mmHg;
• Impaired liver function;

• Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in women and ≥132 g/m² in men);
• New York Heart Association (NYHA) class II-III heart failure;
• Left ventricular ejection fraction > 50%;
• Increased LV filling pressures assessed at rest or at peak exercise by echocardiography
• Body mass index (BMI) > 30 kg/m²
• Signed and data informed consent