EUCTR2013-002513-35-BE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,183
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
- •- 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
- •- BNP =500 pg/mL or N-terminal pro b-type natriuretic peptide (NTproBNP)=
- •2,000 pg/mL
- •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
- •- Known history of respiratory disorders requiring the daily use of
- •IV steroids (does not include inhaled or oral steroids) at least 2
- •months prior to randomization; need for intubation or the current
- •use of IV steroids for COPD
- •-Patients with systolic blood pressure > 180 mmHg at end of screening
- •or persistent heart rate >130 bpm
- •-History of malignancy of any organ system (other than localized
- •basal cell carcinoma of the skin), treated or untreated, within the
- •Other protocol-defined exclusion criteria may apply.
研究者
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