EUCTR2011-002468-26-DK进行中（未招募）1 期
iraglutide in chronic heart failure. A randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE-study). - LIVE
Allan Flyvbjerg0 个研究点开始时间: 2011年8月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •CHF (NYHA-class I, II or III) at visit 0
- •LVEF = 45 % (measured within 30 days prior to visit 1)
- •Age 30 to 85 (both inclusive)
- •Optimal medical treatment in 3 months and stable treatment with ACE-inhibitors, AT2-antagonists, beta-blockers and/or aldosterone antagonists for the last 30 days prior to randomisation (visit 1)
- •Able to understand the written patient information and to give informed consent
- •For patients with diabetes exclusively
- •T2D (WHO criteria), diagnosed at least 3 months prior to visit 0
- •Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
- •Stable dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Myocardial infarction (MI) within the last three months prior to visit 0
- •Coronary revascularization within the last three months prior to visit 0
- •Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1)
- •CHF (NYHA class IV)
- •ECG suggestive of malign ventricular arrhythmia at visit 0
- •Prolonged QT-interval (>500 ms) at visit 0
- •Uncorrected valvular heart disease at visit 0
- •Current myocardial or pericardial infection
- •Obstructive hypertrophic cardiomyopathy
- •Current planned coronary revascularisation
- •Poor image quality on echocardiography
- •Type 1 diabetes
- •HbA1c >10% measured at visit 0
- •Diabetic gastroparesis
- •Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1)
- •Use of insulin other than human NPH-insulin or long-acting insulin analogue within 30 days prior to randomisation (visit 1)
- •Other/general
- •Known or suspected hypersensitivity to trial product or related products
- •Alcohol/drug abuse
- •Pregnant or nursing women
- •Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- •Cancer unless in complete remission for =5 years
- •Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- •Inflammatory bowel disease
- •Acute or chronic pancreatitis
- •Compromised kidney function (eGFR < 30 ml/min), dialysis or kidney transplantation
- •History of thyroidea adenoma or carcinoma
- •Severely elevated blood pressure (systolic >180 mmHg and/or diastolic >105 mmHg)
- •Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- •Simultaneous participation in any other clinical intervention trial
- •Receipt of an investigational drug with 30 days prior to visit 0
研究者
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