A multicenter, randomized, double-blind, placebocontrolled phase III study to evaluate the efficacy, safetyand tolerability of serelaxin when added to standardtherapy in acute heart failure patients - RELAX ASIA

ovartis Healthcare Pvt Ltd0 个研究点目标入组 1,520 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or female >= 18 years of age, with body weight <=160 kg
•Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and the end of screening:
•â?¦Dyspnea at rest or with minimal exertion
•â?¦Pulmonary congestion on chest radiograph
•â?¦Brain natriuretic peptide (BNP) >=350 pg/mL or NT-proBNP >=1,400 pg/mL
•Systolic BP >=125 mmHg at the start and at the end of screening
•Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
•Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of >= 25 and <=75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).

•Dyspnea primarily due to non-cardiac causes.
•Temperature 38.5Â°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).

发起方

ovartis Healthcare Pvt Ltd