This is a single-arm, open label, interventional, multi-center, phase IV pilot study.
- Drug: BisoprololSubjects will receive Bisoprolol at a dose of 1.25 milligram (mg) up to Weeks 3, and then it will be 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.
- Brand name: Concor
|Ages eligible for Study||18 Years to 80 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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).
- 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.
- Please Contact the Merck KGaA Communication CenterrecruitingDarmstadt, Germany
20 March, 2017
02 July, 2017