Empagliflozin and its effect on heart failure in type 2 diabetes - EFFORT

niversitätsklinikum Freiburg Abteilung Endokrinologie und Diabetologie0 个研究点目标入组 72 人开始时间: 2016年11月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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 > 7.0 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
•ADDITIONAL KEY INCLUSION CRITERIA EFFORT-1
•A diagnosis of chronic heart failure
•Left ventricle ejection fraction (LVEF) = 45% during the screening or within 5 months prior to registration
•LVEF > 45% prior to registration

•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. 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
•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 at registration
•12. Known rare are 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

发起方

niversitätsklinikum Freiburg Abteilung Endokrinologie und Diabetologie