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A Single-arm, Interventional, Multi-center, Pilot Study to Evaluate the Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Patients With NYHA Class II - IV (Biso-CHF Study) (NCT03026088)

This is a single-arm, open label, interventional, multi-center, phase IV pilot study.
  • Drug: Bisoprolol
    Subjects 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
Accepts Healthy Volunteers
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.

1 locations

Germany (1)
  • Please Contact the Merck KGaA Communication Center
    Darmstadt, Germany
20 March, 2017
02 August, 2017
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