A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 427
- 试验地点
- 75
- 主要终点
- Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
研究概览
简要总结
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years and older
- •Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP
排除标准
- •Acute de-novo heart failure
- •Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
- •Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
- •Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
研究组 & 干预措施
Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with reduced ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with reduced ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with reduced ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with reduced ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with reduced ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Placebo
Chronic heart failure with reduced ejection fraction
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
时间窗: Baseline, Week 20
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
时间窗: Baseline, Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
次要结局
- Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20(Baseline, Week 20)
- Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20(Baseline, Week 20)
- Number of Participants With Composite Efficacy Outcome(Baseline up to Week 26)
- Number of Participants With Cardiovascular (CV) Mortality(Baseline up to Week 26)
- Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20(Baseline, Week 20)
- Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)(Baseline up to Week 26)