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

niversitätsklinikum Freiburg Abteilung Endokrinologie und Diabetologie0 sites72 target enrollmentNovember 7, 2016

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: E11
Sponsor: niversitätsklinikum Freiburg Abteilung Endokrinologie und Diabetologie
Enrollment: 72
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 7, 2016

End Date

November 19, 2020

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversitätsklinikum Freiburg Abteilung Endokrinologie und Diabetologie

•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

•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