A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure and Preserved Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 305
- 试验地点
- 76
- 主要终点
- Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
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 (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 45 years and older
- •Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP
排除标准
- •Acute decompensated heart failure within the past 4 weeks
- •Inability to exercise
- •Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)
研究组 & 干预措施
Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with preserved ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with preserved ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with preserved ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with preserved ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with preserved ejection fraction
干预措施: Neladenoson bialanate (BAY1067197) (Drug)
Placebo
Chronic heart failure with preserved ejection fraction
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
时间窗: Baseline, and up to 20 weeks of treatment
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
次要结局
- Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks(Baseline, and up to 20 weeks of treatment)
- Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score(Baseline, and up to 20 weeks of treatment)
- Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity(Baseline, and up to 20 weeks of treatment)
- Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks(Baseline, and up to 20 weeks of treatment)