A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 42
- 主要终点
- Change in Six-minute walk distance
研究概览
简要总结
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
详细描述
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo
All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
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)
盲法说明
The blind is maintained by the use of a matching placebo.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, greater than or equal to18 to 85 years of age.
- •NYHA Class II or III or NYHA class IV symptoms.
- •A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- •Qualifying Baseline RHC.
- •Qualifying echocardiogram
- •Qualifying 6-MWD
- •A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
- •Requirements related to child bearing potential, contraception, and egg/sperm donation
排除标准
- •A diagnosis of PH WHO Groups 1, 3, 4, or
- •Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- •Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the presence of significant valve disease
- •A diagnosis of pre-existing lung disease
- •History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- •Major surgery within 60 days.
- •Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
- •History of clinically significant other diseases that may limit or complicate participation in the study.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
TNX-103
oral levosimendan
干预措施: TNX-103 (Drug)
结局指标
主要结局
Change in Six-minute walk distance
时间窗: 12 weeks
次要结局
- KCCQ(12 weeks)
- Clinical Worsening Events(12 weeks)
- Change in NT-proBNP(12 weeks)
- Change NYHA functional class(12 weeks)
- KCCQ(12 weeks)
- Clinical Worsening Events(12 weeks)
- Change in NT-proBNP(12 weeks)
- Change NYHA functional class(12 weeks)