Last updated on July 2014

Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets FIRST

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Systolic Heart Failure
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other:
    aged from 18 to 75 years, males or females
    Willing to provide written informed consent
    NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for
    ≥4 weeks
    Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
    Sinus rhythm with resting heart rate≥70 b.p.m.
    Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within
    previous 1 month

You may not be eligible for this study if the following are true:

  • Unstable cardiovascular condition(for example, hospital admission for worsening heart
    Recent (<2 months) myocardial infarction or recent or scheduled coronary
    Stroke or transient cerebral ischaemia within previous 4 weeks
    Severe primary valvular disease
    Scheduled surgery of valvular heart disease
    Active myocarditis
    Congenital heart diseases
    peripartum cardiomyopathy
    hyperthyroid heart disease
    On list for cardiac transplantation
    Cardiac resynchronization therapy started within previous 6 months
    Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the
    time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.
    Permanent atrial fibrillation or flutter
    Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular
    History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a
    cardioverter/defibrillator implanted
    Cardioverter/defibrillator shock within previous 6 months
    Family history or congenital long QT syndrome or treated with selected QT-prolonging
    products(except amiodarone)
    Contraindication or intolerance to ivabradine or lactulose
    Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)
    known anaemia(Hb<100 g/L)
    Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal
    Pregnant or lactating women and women planning to become pregnant
    Use of an investigational drug within 30 days of enrollment
    Has a history of psychological illness/condition that interferes with ability to
    understand or complete requirements of the study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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