NCT07288398招募中3 期
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 176
- 主要终点
- 6-Minute Walk Distance (6MWD)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
详细描述
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, ≥18 to 85 years of age
- •NYHA Class II or III or ambulatory NYHA Class IV symptoms
- •A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
- •A qualifying baseline RHC
- •A qualifying echocardiogram
- •A 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 5
- •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 Comparator
Matching placebo (oral)
干预措施: Placebo (Drug)
TNX-103
Active Comparator
Oral levosimendan
干预措施: TNX-103 (Drug)
结局指标
主要结局
6-Minute Walk Distance (6MWD)
时间窗: 26 weeks
Change in 6-minute walk distance
次要结局
- KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health.(26 weeks)
- NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity.(26 weeks)
- Clinical Worsening Event(26 weeks)
- Clinical Worsening Events(26 weeks)
研究者
研究点 (176)
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