此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (RELAX-AHF-ASIA)

2019年6月12日 更新者：Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

876

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100050
        • Novartis Investigative Site
      • Chongqing、中国、400037
        • Novartis Investigative Site
      • Shanghai City、中国
        • Novartis Investigative Site
    • Beijing
      • Beijing、Beijing、中国、100039
        • Novartis Investigative Site
      • Beijing、Beijing、中国、100037
        • Novartis Investigative Site
    • Gansu
      • Lanzhou、Gansu、中国、730030
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou、Guangdong、中国、51000
        • Novartis Investigative Site
      • Guangzhou、Guangdong、中国、510515
        • Novartis Investigative Site
    • Jiangsu
      • Suzhou、Jiangsu、中国、215006
        • Novartis Investigative Site
      • Yangzhou、Jiangsu、中国
        • Novartis Investigative Site
    • Liaoning
      • Shenyang、Liaoning、中国、110000
        • Novartis Investigative Site
      • Shenyang、Liaoning、中国、110003
        • Novartis Investigative Site
    • Shanghai
      • Jinshan、Shanghai、中国、201508
        • Novartis Investigative Site
      • Shanghai、Shanghai、中国、200032
        • Novartis Investigative Site
    • Shanxi
      • Xian、Shanxi、中国、710061
        • Novartis Investigative Site
    • Tianjin
      • Tianjin、Tianjin、中国、300121
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310013
        • Novartis Investigative Site
      • Wenzhou、Zhejiang、中国、325000
        • Novartis Investigative Site
  • 印度
      • Rajasthan、印度、334003
        • Novartis Investigative Site
    • Delhi
      • New Delhi、Delhi、印度、110029
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad、Gujarat、印度、380054
        • Novartis Investigative Site
      • Vadodara、Gujarat、印度、390022
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur、Maharashtra、印度、440010
        • Novartis Investigative Site
      • Nagpur、Maharashtra、印度、440012
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai、Tamil Nadu、印度、600101
        • Novartis Investigative Site
    • Telangana
      • Hyderabad、Telangana、印度、500082
        • Novartis Investigative Site
  • 台湾
      • Changhua、台湾、50006
        • Novartis Investigative Site
      • Kaohsiung、台湾、80756
        • Novartis Investigative Site
      • Kaohsiung City、台湾、83301
        • Novartis Investigative Site
      • New Taipei、台湾、22060
        • Novartis Investigative Site
      • Taichung、台湾、40447
        • Novartis Investigative Site
      • Taipei、台湾、10002
        • Novartis Investigative Site
      • Taipei、台湾、11217
        • Novartis Investigative Site
      • Taipei、台湾、10449
        • Novartis Investigative Site
      • Taoyuan、台湾、33305
        • Novartis Investigative Site
      • Yilan、台湾、26058
        • Novartis Investigative Site
  • 大韩民国
      • Busan、大韩民国、602739
        • Novartis Investigative Site
      • Gwangju、大韩民国、61469
        • Novartis Investigative Site
      • Incheon、大韩民国、405 760
        • Novartis Investigative Site
      • Seoul、大韩民国、03080
        • Novartis Investigative Site
      • Seoul、大韩民国、03722
        • Novartis Investigative Site
      • Seoul、大韩民国、02841
        • Novartis Investigative Site
    • Bucheon Si
      • Gyeonggi do、Bucheon Si、大韩民国、422-711
        • Novartis Investigative Site
    • Chungcheongbuk Do
      • Cheongju si、Chungcheongbuk Do、大韩民国、28644
        • Novartis Investigative Site
    • Gangwon-do
      • Wonju、Gangwon-do、大韩民国、26427
        • Novartis Investigative Site
    • Gyeonggi Do
      • Bundang Gu、Gyeonggi Do、大韩民国、13620
        • Novartis Investigative Site
    • Korea
      • Seoul、Korea、大韩民国、05505
        • Novartis Investigative Site
      • Seoul、Korea、大韩民国、06351
        • Novartis Investigative Site
      • Seoul、Korea、大韩民国、08308
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul、Seocho Gu、大韩民国、06591
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、169609
        • Novartis Investigative Site
      • Singapore、新加坡、117549
        • Novartis Investigative Site
  • 日本
      • Osaka、日本、534-0021
        • Novartis Investigative Site
      • Saitama、日本、330 8503
        • Novartis Investigative Site
    • Aichi
      • Nagakute-city、Aichi、日本、480-1195
        • Novartis Investigative Site
      • Seto-city、Aichi、日本、489-8642
        • Novartis Investigative Site
    • Chiba
      • Kamogawa-city、Chiba、日本、2968602
        • Novartis Investigative Site
    • Ehime
      • Saijo-city、Ehime、日本、793-0027
        • Novartis Investigative Site
    • Fukuka
      • Chikushino-city、Fukuka、日本、818-8516
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city、Fukuoka、日本、810-0001
        • Novartis Investigative Site
      • Fukuoka-city、Fukuoka、日本、811-0213
        • Novartis Investigative Site
      • Fukuoka-city、Fukuoka、日本、815-8588
        • Novartis Investigative Site
      • Iizuka-city、Fukuoka、日本、820-8505
        • Novartis Investigative Site
      • Kurume-city、Fukuoka、日本、830-8543
        • Novartis Investigative Site
      • Kurume-city、Fukuoka、日本、830-8577
        • Novartis Investigative Site
    • Gifu
      • Ogaki-city、Gifu、日本、503-8502
        • Novartis Investigative Site
    • Hokkaido
      • Kushiro-city、Hokkaido、日本、085-0062
        • Novartis Investigative Site
      • Sapporo-city、Hokkaido、日本、006-8555
        • Novartis Investigative Site
    • Hyogo
      • Amagasaki city、Hyogo、日本、660 8550
        • Novartis Investigative Site
      • Kobe-City、Hyogo、日本、654-0155
        • Novartis Investigative Site
    • Ibaraki
      • Mito-city、Ibaraki、日本、311-4198
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa、Ishikawa、日本、920 8650
        • Novartis Investigative Site
    • Kagawa
      • Kanonji-city、Kagawa、日本、769-1695
        • Novartis Investigative Site
      • Takamatsu city、Kagawa、日本、760 8557
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city、Kanagawa、日本、211-8533
        • Novartis Investigative Site
      • Yokohama city、Kanagawa、日本、232 0024
        • Novartis Investigative Site
      • Yokohama-city、Kanagawa、日本、236 0051
        • Novartis Investigative Site
      • Yokohama-city、Kanagawa、日本、227-8501
        • Novartis Investigative Site
      • Yokohama-city、Kanagawa、日本、231-8682
        • Novartis Investigative Site
    • Kochi
      • Kochi city、Kochi、日本、781 8555
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto-city、Kumamoto、日本、861-4193
        • Novartis Investigative Site
      • Yatsushiro-city、Kumamoto、日本、866-8660
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city、Kyoto、日本、607-8062
        • Novartis Investigative Site
      • Uji-city、Kyoto、日本、611-0042
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city、Miyagi、日本、981-3133
        • Novartis Investigative Site
    • Nagano
      • Nakano-city、Nagano、日本、383-8505
        • Novartis Investigative Site
      • Saku-city、Nagano、日本、3850051
        • Novartis Investigative Site
      • Ueda-city、Nagano、日本、386-8610
        • Novartis Investigative Site
    • Niigata
      • Niigata-city、Niigata、日本、950-1197
        • Novartis Investigative Site
    • Osaka
      • Osaka-city、Osaka、日本、540-0006
        • Novartis Investigative Site
    • Saitama
      • Kawaguchi-city、Saitama、日本、333-0842
        • Novartis Investigative Site
      • Sayama-city、Saitama、日本、350-1323
        • Novartis Investigative Site
      • Wako-city、Saitama、日本、351-0102
        • Novartis Investigative Site
    • Shiga
      • Kusatsu city、Shiga、日本、525 8585
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu-city、Shizuoka、日本、430-8558
        • Novartis Investigative Site
      • Kakegawa-city、Shizuoka、日本、436-8555
        • Novartis Investigative Site
    • Tokyo
      • Akishima-city、Tokyo、日本、196-0003
        • Novartis Investigative Site
      • Chuo ku、Tokyo、日本、104-8560
        • Novartis Investigative Site
      • Hachioji-city、Tokyo、日本、192-0918
        • Novartis Investigative Site
      • Itabashi-ku、Tokyo、日本、173-8610
        • Novartis Investigative Site
      • Musashino-city、Tokyo、日本、180-8610
        • Novartis Investigative Site
      • Shinagawa ku、Tokyo、日本、141 8625
        • Novartis Investigative Site
      • Shinagawa-ku、Tokyo、日本、142-8666
        • Novartis Investigative Site
    • Wakayama
      • Tanabe-city、Wakayama、日本、646-8558
        • Novartis Investigative Site
  • 泰国
      • Bangkok、泰国、10330
        • Novartis Investigative Site
      • Bangkok、泰国、10700
        • Novartis Investigative Site
      • Bangkok、泰国、10400
        • Novartis Investigative Site
      • Chiang Mai、泰国、50200
        • Novartis Investigative Site
      • Muang、泰国、40002
        • Novartis Investigative Site
    • Hat Yai
      • Songkhla、Hat Yai、泰国、90110
        • Novartis Investigative Site
  • 约旦
      • Amman、约旦、11183
        • Novartis Investigative Site
      • Amman、约旦、11184
        • Novartis Investigative Site
    • JOR
      • Amman、JOR、约旦、11152
        • Novartis Investigative Site
  • 菲律宾
      • Makati City、菲律宾、1229
        • Novartis Investigative Site
      • Manila、菲律宾、1003
        • Novartis Investigative Site
      • Pasig City、菲律宾、1605
        • Novartis Investigative Site
      • Quezon City、菲律宾、1102
        • Novartis Investigative Site
      • Quezon City、菲律宾、1113
        • Novartis Investigative Site
      • San Juan City、菲律宾、1500
        • Novartis Investigative Site
    • Manila
      • Quezon City、Manila、菲律宾、1100
        • Novartis Investigative Site
    • Metro Manila
      • Manila、Metro Manila、菲律宾、1000
        • Novartis Investigative Site
  • 马来西亚
      • Kuala Lumpur、马来西亚、59100
        • Novartis Investigative Site
      • Kuala Lumpur、马来西亚、50400
        • Novartis Investigative Site
    • MYS
      • Kuala Lumpur、MYS、马来西亚、56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu、Sabah、马来西亚、88300
        • Novartis Investigative Site
    • Sarawak
      • Kuching、Sarawak、马来西亚、94300
        • Novartis Investigative Site
    • Selangor Darul Ehsan
      • Kuala Lumpur、Selangor Darul Ehsan、马来西亚、43000
        • Novartis Investigative Site
      • Sungai Buloh、Selangor Darul Ehsan、马来西亚、47000
        • Novartis Investigative Site
  • 黎巴嫩
      • Ashrafieh、黎巴嫩、166830
        • Novartis Investigative Site
      • Beirut、黎巴嫩、1107 2020
        • Novartis Investigative Site
      • Beirut、黎巴嫩
        • Novartis Investigative Site
      • Hazmieh、黎巴嫩、470
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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 at the end of screening:

    • Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
    • Pulmonary congestion on chest radiograph
    • Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
  • Systolic BP ≥125 mmHg at the start and at the end of screening
  • Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
  • 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).

Exclusion Criteria:

  • Dyspnea primarily due to non-cardiac causes
  • Temperature >38.5°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).

  • Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment

    *Patients with systolic blood pressure >180 mmHg at the end of screening

  • AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute

  • Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).

    *Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis

  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
药品：安慰剂
静脉输液
其他：Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
实验性的：Serelaxin
Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.
其他：Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
药品：松弛素
静脉输液

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
大体时间：through day 5
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
through day 5

次要结果测量

结果测量
措施说明
大体时间
Time to WHF
大体时间：Through Day 5
Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).
Through Day 5
Time to CV Death
大体时间：Through Day 180
analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).
Through Day 180
Time to All-cause Death
大体时间：Through Day 180
Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).
Through Day 180
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
大体时间：Through Day 5
Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale
Through Day 5
Dyspnea by VAS-AUC Changes
大体时间：Through Day 5
Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours
Through Day 5
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
大体时间：Up to day 30
Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
Up to day 30
Renal Dysfunction and Prevention of Worsening of Renal Function
大体时间：Through Day 5
number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5
Through Day 5
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
大体时间：Through Day 180
Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment
Through Day 180
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
大体时间：Through Day 180
Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).
Through Day 180
Time to In-hospital Worsening Heart Failure Through Day 5
大体时间：Through Day 5
Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.
Through Day 5
Use of Loop Diuretic and Vasoactive Agents
大体时间：Through Day 5
Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5
Through Day 5
Change From Baseline in Cardio-renal Biomarkers
大体时间：Day 2 and Day 5
Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
大体时间：For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.
To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年3月12日

初级完成 (实际的)

2017年3月27日

研究完成 (实际的)

2017年6月16日

研究注册日期

首次提交

2013年11月20日

首先提交符合 QC 标准的

2013年12月9日

首次发布 (估计)

2013年12月11日

研究记录更新

最后更新发布 (实际的)

2019年8月2日

上次提交的符合 QC 标准的更新

2019年6月12日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CRLX030A2302

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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