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

NCT ID: NCT03026088

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2018-12-26

Brief Summary

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

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bisoprolol

Group Type: EXPERIMENTAL

Bisoprolol

Intervention Type: DRUG

Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was 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.

Interventions

Bisoprolol

Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was 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.

Intervention Type: DRUG

Other Intervention Names

Brand name: Concor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono Co., Ltd., China

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono Co., Ltd., China

Locations

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MS200006-0039

Identifier Type: -

Identifier Source: org_study_id