Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants (Biso-CHF)

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 4

Conditions

Heart Failure

Treatments

Drug: Bisoprolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT03026088

MS200006-0039

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.