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临床试验/EUCTR2009-017082-39-HU
EUCTR2009-017082-39-HU进行中（未招募）不适用

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF) within 12 hours after hospital admission (Pulmonary Artery Catheter eg, Swan-Ganz not required) - COMPOSE EARLY

Bayer Healthcare AG0 个研究点目标入组 160 人开始时间: 2010年7月5日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
160
研究概览入排标准研究者记录与标识符相似试验

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

  • •Able to commence treatment within 12 hours of hospital admission (including
  • •emergency department)
  • •Subjects with ADHF, NYHA functional class III-IV requiring hospitalization
  • •Subjects must have the clinical diagnosis of CHF, either ischemic or non-ischemic,
  • •made at least three months prior to enrollment and a history of heart failure
  • •hospitalization or IV diuretic treatment required within the last 12 months
  • •Treatment with IV diuretic (after hospital admission)
  • •Subjects must experience worsening of both of the symptoms listed below leading
  • •to hospitalization admission up to study run-in. Worsening of these symptoms does
  • •not need to be displayed at baseline.
  • •o Dyspnea symptoms
  • •Dyspnea (labored or difficult breathing) at rest
  • •Dyspnea (labored or difficult breathing) on minimal exertion
  • •Orthopnea (difficult breathing except in the upright position)
  • •Nocturnal dyspnea (awaken from sleep due to respiratory
  • •o Clinical evidence of volume overload:
  • •Peripheral edema
  • •Hepatic congestion with ascites
  • •Rales or pulmonary congestion (confirmed by chest X-ray)
  • •Jugular venous distension
  • •Left ventricular ejection fraction < 40 % within the last 12 months
  • •Systolic blood pressure at inclusion of the study = 120 mmHg and = 180 mmHg
  • •Heart rate < 100 beats per minute
  • •Ability to understand and willing to sign informed consent form (subject or legal
  • •representative)
  • •Subject is capable of self-assessing his/her well being by applied scales after
  • •Instruction
  • •Women without childbearing potential defined as postmenopausal women aged
  • •55 years or older, women with bilateral tubal ligation, women with bilateral
  • •ovarectomy, and women with hysterectomy
  • •Males and non-pregnant, non-lactating females, 18 years of age or older. For
  • •females of child-bearing potential, one of the following medically acceptable
  • •contraceptive methods must be used or they agree to abstain from heterosexual
  • •intercourse while participating in the study. One or more of these methods should
  • •be used during the study and continue for 30 days after completion of the study:
  • •a) Double-barrier methods of contraception (eg, condoms plus spermicidal
  • •b) Intrauterine contraceptive device
  • •c) Approved pharmaceutical contraceptive product (eg, birth control pills or
  • •patches, long-term injectable or implantable hormonal contraceptive)
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Acute de-novo heart failure
  • •Acute myocardial infarction and/or myocardial infarction within 30 days
  • •Valvular heart disease requiring surgical intervention during the course of the study
  • •Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning
  • •artificial heart valve, or uncorrected congenital heart disease
  • •Primary hypertrophic cardiomyopathy
  • •Acute inflammatory heart disease, eg, acute myocarditis
  • •Unstable angina requiring angiography
  • •Cardiogenic shock
  • •Subjects requiring any of the following medication: any vasodilating drug (eg,
  • •nitrates, sodium nitroprusside), any intravenous positive inotropic drug (eg,
  • •levosimendan, dobutamine), or any natriuretic petide (eg, nesiritide, carperitide)
  • •within the last three hours prior to dosing with study medication
  • •Need for endotracheal intubation and mechanical ventilation
  • •Subjects with cardiac arrest or subjects with history of cardiac arrest within three
  • •months, unless precipitated by an event such as an acute myocardial infarction,
  • •induction by catheter placement, severe transient electrolyte abnormality, an
  • •electrophysiology procedure, or addressed by automatic implantable cardioverter
  • •defibrillator placement
  • •Subjects with increased risk of cardiac arrest (eg, QTc > 450 msec, atrial
  • •ventricular block II or III)
  • •Sustained ventricular tachycardia within 30 days (duration > 15 seconds)
  • •Subjects showing during ECG monitoring sustained or unsustained ventricular
  • •tachycardia, either monomorphic or polymorphic (unless precipitated by an event
  • •such as catheter placement)
  • •Uncontrolled atrial fibrillation or flutter or any supraventricular tachycardia with a
  • •ventricular rate more than 110 bpm for more than 30 minutes
  • •Cardiac surgery within the last month (such as cardiac revascularization surgery,
  • •valvular surgery, biventricular resynchronization procedure, ventricular reduction
  • •surgery or cardiac myoplasty, implantation of mechanical ventricular assist device)
  • •Pulmonary embolism within the last 30 days prior to enrollment
  • •PDE 3 inhibitor use within the last 48 hours prior to onset of study drug infusion
  • •Strong CYP2C8 inhibitors like gemfibrozil (stop at least 24 hours before study
  • •drug infusion)
  • •Heart failure secondary to pulmonary disease and subjects with primary pulmonary
  • •arterial hypertension and chronic thromboembolic pulmonary hypertension
  • •History of or clinically significant evidence of any severe disease other than heart
  • •failure that preclude participation
  • •Clinical relevant hepatic dysfunction (eg, induced by acute clinical hepatitis,
  • •chronic active hepatitis, cirrhosis) indicated by:
  • •- bilirubin > 2 times upper limit normal
  • •- and/or hepatic transaminases > 3 times upper limit normal
  • •- and/or signs of severe hepatic insufficiency (eg, impaired albumin synthesis
  • •with albumin < 35g/l, hepatic encephalopathy > Stage 1 (according to West
  • •Haven Criteria of Altered Mental Status In Hepatic Encephalopathy: Stage
  • •0: Lack of detectable personality changes. No asterixis; Stage 1: Trivial
  • •lack of awareness. Impaired attention span. Altered sleep, euphoria or
  • •depression. Mild asterixis may be present; Stage 2: Lethargy or apathy.
  • •Disorientation. Inappropriate behavior. Slurred speech. Asterixis; Stage 3:
  • •Gross disorientation. Bizarre behavior. Semi-stupor. Asterixis absent; Stage
  • 另有 3 项未显示

研究者

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