Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants

• Status: Terminated
• Trial end date: 2018-12-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd., China
• Treatments: Bisoprolol

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.