EUCTR2013-002513-35-GB进行中（未招募）1 期
A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients. - RELAX AHF_Pan E
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,650
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
入选标准
- •- Male or female = 18 years of age with body weight = 40 Kg and = 160
- •- Systolic blood pressure =125 mmHg at the beginning of the screening
- •period (after ICF signature) and at the end of the screening period (prior
- •to randomization)
- •- Admitted for AHF: Persistent dyspnea at rest or with minimal exertion,
- •Pulmonary congestion assessed through physical examination and chest
- •- Furosemide at any time between admission and the start of screening
- •- eGFR on admission: =25 and =75 mL/min/1.73 m2
- •Other protocol-defined inclusion criteria may apply.
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2483
排除标准
- •- Dyspnea (non-cardiac causes) such as acute or chronic respiratory
- •disorders or infections (i.e., severe chronic obstructive pulmonary
- •disease, bronchitis, pneumonia), or primary pulmonary hypertension
- •sufficient to cause dyspnea at rest, which may interfere with the ability
- •to interpret the primary cause of dyspnea.
- •- T >38.5°C
- •- Clinical evidence of acute coronary syndrome
- •- AHF due to arrhythmias, acute myocarditis or cardiomyopathy
- •Other protocol-defined exclusion criteria may apply.
- •Other protocol-defined exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF)patients.EUCTR2013-002513-35-ESovartis Farmacéutica, S. A.2,685
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.EUCTR2013-002513-35-PLovartis Pharma Services AG3,183
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.Acute heart failureEUCTR2013-002513-35-HRovartis Pharma Services AG3,183
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.EUCTR2013-002513-35-GRovartis Pharma Services AG2,685
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.Acute heart failureEUCTR2013-002513-35-EEovartis Pharma Services AG2,650