NCT03026088终止4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Resting Heart Rate at Week 14
研究概览
简要总结
This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Bisoprolol
Experimental
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Change From Baseline in Resting Heart Rate at Week 14
时间窗: Baseline, Week 14
Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
Change From Baseline in Resting Heart Rate at Week 6
时间窗: Baseline, Week 6
Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
Change From Baseline in Resting Heart Rate at Week 26
时间窗: Baseline, Week 26
Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
次要结局
- Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26(Baseline, Week 14 and 26)
- Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26(Baseline, Week 14 and 26)
- Change From Baseline in Resting Heart Rate at Week 3, 10 and 18(Baseline, Week 3, 10 and 18)
- Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26(Baseline, Week 14 and 26)
- Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26(Baseline, Week 14 and 26)
- Mean 24 Hour, Day Time and Night Time Heart Rate(Baseline, week 6, 14 and end of treatment (Week 26))
- Number of Participants With Arrhythmia(Baseline up to end of treatment (Week 26))
- Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm(Baseline, week 6, 14 and end of treatment (Week 26))
- Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26(Baseline, Week 14 and Week 26)
- 6-Minute Walk Test(Baseline and End of treatment (Week 26))
- Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure(Screening (Week -2) up to Week 26)
- Number of Participants With New York Heart Association (NYHA) Class(Baseline, Week 26)
- Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm(Baseline up to Week 26)
- Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment(Baseline, end of treatment (Week 26))
- Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)(Up to Week 26)
- Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure(Up to Week 26)
- Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment(Baseline, end of treatment (Week 26))
- Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)(Baseline up to End of treatment (Week 26))
研究者
研究点 (1)
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