EUCTR2016-003653-15-HU进行中（未招募）1 期
A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease - SERENADE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signs or symptoms of Heart Failure (HF) (NYHA FC II and III) requiring treatment with at least one oral diuretic (any type)
- •Left Ventricular ejection fraction (LVEF) = 40% (by echocardiography at Screening)
- •Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
- •Elevated NT-proBNP
- •Pulmonary vascular disease or right ventricular dysfunction
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Any prior valid measurement of LVEF < 40%.
- •Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
- •Systolic blood pressure (SBP) = 180 mmHg, or diastolic blood pressure (DBP) = 110 mmHg during Screening
- •Hemoglobin < 100g/L (< 10 g/dl).
- •Significant parenchymal lung disease (e .g., severe COPD, moderate or severe restrictive lung disease , diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
- •Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR ) < 30 m L/min per 1.73 m2
- •Severe hepatic impairment, e .g., Child Pugh Class C.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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