ACTRN12609000998246已完成1 期
An Exploratory, Single Centre, Open Label, single and Multidose, Safety and Efficacy Study of the Treatment of Acute Decompensated Congestive Heart Failure with Vessel Dilator Peptide by Intravenous Infusion.
Madeleine Pharmaceuticals0 个研究点目标入组 36 人开始时间: 2009年11月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Upon diagnosis of ADCHF (New York Heart Association (NYHA) class III - NYHA class IV) with evidence of the following:
- •1. Signed written informed consent
- •2. Male and/or female, 18 years or older
- •3. Women of child bearing potential to test negative to beta-human chorionic gonadotropin (ß-hCG)
- •4.Systolic dysfunction within the last 12 months (EF <40%) as determined by Trans-Thoracic Echocardiogram (TTE)
排除标准
- •1. Evidence in the Emergency Department (ED) for Myocardial Infarction (MI) or high risk acute coronary syndrome within past 6 weeks, as determined by creatinine kinase (CK)/creatinine kinase muscle-brain isoenzyme (CK-MB) = 3 times upper limit of normal (as defined by Institute of Medical and Veterinary Science (IMVS)) or elevation of troponin T at baseline >0.1
- •2. Evidence in the ED of Acute MI (ST elevation and/or elevation of Troponin T), as determined by Trans-Thoracic electrocardiogram (TTE)
- •3. Hypotension (Systolic Blood Pressure (SBP)<90 mmHg), cardiogenic shock, volume depletion or any other clinical condition that would contraindicate administration of an Intravenous (IV) agent with potent vasodilatory effects
- •4. Persistent, uncontrolled hypertension (SBP>180 mm Hg)
- •5. Presence any Cardiac Magnetic Resonance (CMR) contra-indication (includes Permanent Pacemaker (PPM), cerebral aneurysm clips,
- •6. Congenital heart defects
- •7. Cardiac surgery within past 4 weeks
- •8. Diastolic heart failure (preserved left ventricular function - determined by history or elctrocardiogram (ECG))
- •9.Severe valvular heart disease: Aortic stenosis (AS), Ideopathic hypertrophic subaortic stenosis (IHSS), Hypertrpohic Obstructive Cardiomyopathy (HOCM), acute Aortic Incompetence (AI) and Mitral Regurgitation (MR)
- •10.History of cerebrovascular accident (within past 4 weeks)
- •11.Acute or chronic active infection, including pneumonia and urinary tract infection
- •12.Significant renal impairment as determined by a creatinine clearance of <60 ml/min
- •13.Prior participation in any other clinical trial within past 30 days, including present day
研究者
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