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

ovartis Pharma Services AG0 个研究点目标入组 3,183 人开始时间: 2014年9月3日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•- Male or female = 18 years of age with body weight = 40 Kg and = 160 Kg
•- 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 X-Ray
•- 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

•- 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 past year.
•Other protocol-defined exclusion criteria may apply.

发起方