Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Bisoprolol
Intervention description: Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
Intervention MeSH terms: Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Bisoprolol; Heart rate control

Summary:

      This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-80 year, male or female.

          -  Chronic Heart failure subjects with medical history of cardiac disease or other
             related cardiovascular disease.

          -  Left ventricular ejection fraction (LVEF) less than or equal to (=<) 40 percent (%).

          -  New York Heart Association (NYHA) class of II - IV

          -  NYHA II ： Slight limitation of physical activity. Comfortable at rest, but ordinary
             physical activity results in undue breathlessness, fatigue or palpitation.

          -  NYHA III：Marked limitation of physical activity. Comfortable at rest, but less than
             ordinary activity causes undue breathlessness, fatigue or palpitation.

          -  NYHA IV：Unable to carry on any physical activity without discomfort. Symptoms at rest
             can be present. If any physical activity is undertaken, discomfort increased.

          -  Signed Informed Consent Form (ICF).

        Exclusion Criteria:

          -  Acute coronary syndrome (ACS) within 3 months.

          -  Under beta-blocker treatment for the last 2 weeks.

          -  Under other medicine treatment which may affect heart rate, like Non-dihydropyridine
             calcium channel blockers (NDHP-CCBs) or ivabradine for the last 2 weeks; Under Digoxin
             treatment [more than (>) 0.125 milligram (mg)].

          -  Uncontrolled Diabetes [hemoglobin A1c, (HbA1c) >7.5%].

          -  Severe or uncontrolled hypertension [resting Systolic Blood Pressure (SBP) >180
             millimeters of mercury (mmHg), or resting Diastolic Blood Pressure (DBP) >110mmHg at
             screening period].

          -  Severe hypotension [resting SBP less than (<) 90mmHg, or resting DBP<50mmHg].

          -  Resting heart rate <60 beat per minute (bpm).

          -  Any contradiction to Bisoprolol according to label, including:

          -  Acute heart failure or during episodes of heart failure decompensation requiring
             intravenous inotropic therapy.

          -  Cardiogenic shock.

          -  Atrioventricular block of second or third degree (without a pacemaker).

          -  Sick sinus syndrome.

          -  Sinoatrial block.

          -  Slowed heart rate, causing symptoms (symptomatic bradycardia),

          -  Decreased blood pressure, causing symptoms (symptomatic hypotension),

          -  Severe bronchial asthma or severe chronic obstructive pulmonary disease.

          -  Sever forms of peripheral arterial occlusive disease and Raynaud's syndrome.

          -  Untreated phaeochromocytoma.

          -  Metabolic acidosis.

          -  Hypersensitivity to bisoprolol or to any of the excipients.

          -  Severe Arrhythmia including atrial fibrillation, atrial flutter, ventricular
             fibrillation, ventricular flutter or ventricular tachycardia.

          -  Significant valvular heart disease, congenital heart disease, pulmonary heart disease
             or perinatal heart disease.

          -  Acute pulmonary edema.

          -  Severe hepatic dysfunction, defined as:

          -  Serum Alanine Aminotransferase (ALT) > triple the upper limit of the normal range;
             and/or

          -  Serum Aspartate Aminotransferase (AST) > triple the upper limit of the normal value
             range and/or

          -  Severe renal dysfunction, defined as:

          -  Serum creatinine > twice the upper limit of the normal range

          -  Chronic Kidney Disease (glomerular filtration rate <45 Milliliter per minute).

          -  Hyperthyroidism or hypothyroidism.

          -  Severe infectious disease, example (eg) Human Immunodeficiency Virus positive or
             active tuberculosis.

          -  Severe autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.

          -  Severe respiratory, digestive, hematological disease (including Anemia of Hb < 100
             gram per litre) or tumor.

          -  Known to be hypersensitivity to Bisoprolol, or any of the excipient.

          -  Substance or alcohol abuse.

          -  Received heart transplantation or pacemaker implantation; revascularization treatment
             within 3 months; or plan to receive above treatment in 6 months.

          -  Currently undertaking other treatment that may affect the safety and/or efficacy
             evaluation, e.g. beta receptors agonists, et cetera.

          -  No legal ability or legal ability is limited.

          -  Subjects unlikely to cooperate in the study or with inability or unwillingness to give
             informed consent.

          -  Child-bearing period women without effective contraceptive measures, pregnancy and
             lactation.

          -  Participation in another clinical trial within the past 90 days.

          -  Other significant condition that in the Investigator's opinion would exclude the
             subject from the trial.