A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 477
- 主要终点
- Change From Baseline to Week 12 in Left Atrial Volume (LAV)
研究概览
简要总结
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)
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
- •Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
- •Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
排除标准
- •Intravenous inotropes at any time after hospitalization
研究组 & 干预措施
Vericiguat (BAY1021189) (2.5 mg)
2.5 mg orally once daily for 12 weeks (with sham titrations)
干预措施: Vericiguat (BAY1021189) (1.25 mg) (Drug)
Vericiguat (BAY1021189)(10 mg)
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
干预措施: Vericiguat (BAY1021189) (1.25 mg) (Drug)
Vericiguat (BAY1021189)(10 mg)
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
干预措施: Vericiguat (BAY1021189) (5 mg) (Drug)
Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
干预措施: Vericiguat (BAY1021189) (1.25 mg) (Drug)
Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
干预措施: Vericiguat (BAY1021189) (5 mg) (Drug)
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg orally once daily for 12 weeks (with sham titrations)
干预措施: Vericiguat (BAY1021189) (1.25 mg) (Drug)
Placebo
Orally once daily for 12 weeks (with sham titrations)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
时间窗: Baseline, Week 12 (EOT)
Left atrial volume was measured by echocardiography.
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
时间窗: Baseline, Week 12 (end of treatment [EOT])
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
次要结局
未报告次要终点