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

niversitätsklinikum Freiburg0 sites270 target enrollmentMay 30, 2016

Overview

No summary available.

Registry

who.int

Start Date

May 30, 2016

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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