IVABRADINE TAB
Clinical Criteria Summary
Exclusion Criteria
- Acute decompensated heart failure
- Recent myocardial infarction (within the past 2 months)
- Cardiac resynchronization therapy started (within past 6 months)
- Atrial fibrillation or atrial flutter
- Congenital heart disease as etiology of heart failure
- Primary severe valvular heart disease as etiology of heart failure
- Clinically significant hypotension
- Sick sinus syndrome, sinoatrial block or 2nd or 3rd degree atrioventricular block (unless a functioning demand pacemaker is present)
- Pacemaker with atrial or ventricular pacing greater than 40% of the time, or with stimulation threshold at the atrial or ventricular level at least 60 beats per minute
- Family history or congenital long QT syndrome or treated with selected QT-prolonging agents
- Concomitant Class I antiarrhythmic agents
- Concomitant diltiazem or verapamil
- Concomitant strong or moderate CYP3A4 inhibitors, or CYP3A4 inducers
- Severe hepatic impairment (Child-Pugh C)
Inclusion Criteria
- Provider Requirement: Initial prescription must be provided by a VA/VA Community Care cardiologist or other locally designated provider.
- Indication 1: Stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction (≤35%), on guideline-directed medical therapy including a beta-blocker at maximum tolerated dose (or unable to use), in normal sinus rhythm, with resting heart rate at least 70 bpm.
- Indication 2: Symptomatic inappropriate sinus tachycardia with persistent symptoms despite treatment with a beta-blocker, or unable to use a beta-blocker.
- Heart Rate Measurement Standard: Resting heart rate must be measured by 12-lead electrocardiogram after at least 5 minutes rest on 2 consecutive visits.
Additional Inclusion Criteria
- Females of Childbearing Potential: For patients who can become pregnant, counseling must be provided on potential risks vs benefits of treatment and the use of effective contraception during therapy.