Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants
Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants
This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
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.