Prospective, Open-labeled Trial in Patients With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea (PRISM)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26
研究概览
简要总结
This is a prospective, open-labeled, multi-centric trial to evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers of heart failure in Korea.
详细描述
Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of NT-proBNP, global assessment of CHF, 6-minute walking test and improvement score of New York Heart Association (NYHA) and echocardiogram (left ventricular chamber size and ejection fraction [LVEF]). Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated up to 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is greater than (>) 90 millimeter of mercury (mm Hg) and there is no symptom of hypotension at the current dose medication (syncope, loss of consciousness, dizziness when standing up).
OBJECTIVES
Primary objective:
• To evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers of heart failure in Korea
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects with heart failure and at the age of 18 (inclusive) to 80 (exclusive)
- •Subjects with NYHA Class II-IV with dyspnea
- •Subjects with left ventricular ejection fraction (LVEF) of 40 percent or below on the echocardiogram
- •Eligible subjects who meet the criteria, are capable of participating in the study, and provide written informed consent to study participation after receiving a clear explanation about the study objective and nature
排除标准
- •A subject who cannot understand or does not agree to the study contents
- •Subjects with conduction defect of 2nd degree or above atrioventricular block
- •Subjects with heart rate less than (<) 60 beats at rest
- •Subjects with systolic blood pressure < 100 mm Hg at rest
- •Subjects with renal failure (serum creatinine > 2.0 milligram per deciliter [mg/dL])
- •Subjects with unrecovered pulmonary edema
- •Subjects with history of myocardial infarction or stroke within 3 months
- •Subjects with history of coronary intervention or coronary bypass within 6 months
- •Subjects with heart failure due to mitral valve without valve replacement or aortic valvular disease (excluding moderate or less severe mitral insufficiency secondary to left ventricular expansion)
- •Subjects with history of valve replacement within the past 6 months
- •Subjects with history or scheduled heart transplantation
- •Subjects with reversible obstructive pulmonary disease
- •Subjects with other cases where beta blockers are contraindicated
- •Any surgical or internal disease that may put the subject at a higher risk due to study participation or may interfere with the subjects compliance to study requirements or completion of the study, based on the judgment of the Investigator
- •A subject with history of non-compliance to drug prescriptions or who is not willing to comply with the protocol
- •Subjects with a history of treated or untreated malignant tumor within the past 5 years
- •Pregnant or lactating women
- •Subjects with heart failure due to acute myocarditis
- •Subjects with continuous ventricular tachycardia with history of syncope within 3 months
研究组 & 干预措施
Low Dose Bisoprolol
干预措施: Low Dose Bisoprolol (Drug)
High Dose Bisoprolol
干预措施: High Dose Bisoprolol (Drug)
结局指标
主要结局
Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26
时间窗: Baseline and Week 26
B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100\*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.
次要结局
- Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)(Baseline and Week 26)
- Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26(Baseline and Week 26)
- Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26(Baseline and Week 26)
- Change From Baseline in Echocardiographic Left Ventricular Size at Week 26(Baseline and Week 26)
- Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder(Baseline up to Week 26)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 26)
- Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26(Baseline and Week 26)