efficacy of oral bisoprolol on heart rate reduction in chinese chronic heart failure participants

Conditions: Heart Failure

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.

Keywords: chronic heart failure bisoprolol heart rate control