EUCTR2016-000214-30-DE进行中（未招募）1 期
Empagliflozin and its effect on heart failure in type 2 diabetes - EFFORT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •1.Male or female patients aged > 18 years and = 85 years old
- •2.A diagnosis of type 2 diabetes mellitus with duration = 3 months
- •3.HbA1c = 6.5 and = 10.0% at screening
- •4.NYHA class I-IV
- •5.Treatment with one or two oral anti-diabetic medications (metformin, DPP-IV inhibitors, GLP-1 receptor agonists, acarbose, sulfonylureas) or treatment with any insulin alone or in combination with one or two oral anti-diabetic medications
- •6.Estimated glomerular filtration rate (eGFR) = 45 ml/min/1.73cm²
- •7.Written informed consent obtained according to international guidelines and local laws
- •8.Ability to understand the nature of the trial and the trial related procedures and to comply with them
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Type 1 diabetes mellitus
- •2.Treatment with empagliflozin or other SGLT-2 inhibitors for more than 7 consecutive days within 2 months prior to registration
- •3.Treatment with pioglitazone or other glitazones at registration
- •4.Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes within 30 days prior to registration
- •5.Current acute decompensated HF requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs within 30 days prior to registration
- •6.History of stroke or cardiac surgery, or percutaneous coronary intervention within 60 days prior to registration
- •7.Transcatheter/transapical aortic valve Implantation (TAVI) or MitraClip procedure within six months preceding registration
- •8.Implantation of cardiac resynchronisation therapy (CRT) device or cardiac contractility modulation (CCM) device within six months preceding registration (for implantable cardioverter-defibrillator (ICD) and pacemaker a necessary lapse of time prior registration will be defined by the investigator)
- •9.Uncontrolled hypertension (systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg measured in resting seated position for 10 minutes)
- •10.Symptomatic hypotension, or an SBP < 85 mmHg
- •11.Blood haemoglobin < 10 g/dl
- •12.Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- •13.Severe hepatic impairment
- •14.Known latent autoimmune diabetes in adults (LADA) or chronic pancreatitis
研究者
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