| 538 | For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (LVEF) (less than or equal to 35%) in adult patients with New York Heart Association (NYHA) classes II or III who are in sinus rhythm with a resting heart rate greater than or equal to 77 beats per minute (bpm), to reduce the incidence of cardiovascular mortality and hospitalizations for worsening heart failure, administered in combination with standard chronic heart failure therapies if the following are met:
- Patients with NYHA class II to III symptoms despite at least four weeks of treatment with a stable dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) in combination with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA); AND
- Patients with at least one hospitalization due to heart failure in the last year; AND
- Resting heart rate must be documented as greater than or equal to 77 bpm on average using either an ECG on at least three separate visits or by continuous monitoring. |
