Heart failure and type 2 diabetes MedDRA version: 20.0 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the EFFORT study is to investigate effects of empagliflozin on quality of life in diabetic patients with HFrEF or HFpEF.;Secondary Objective: The secondary objectives are to evaluate cognitive function, cardiac performance, structural changes of the heart, HF symptoms, changes in biomarkers after treatment with empagliflozin as compared to placebo.;Primary end point(s): Change in quality of life assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ) total score 6 months after randomization as compared to baseline.;Timepoint(s) of evaluation of this end point: Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) • Cognitive function assessed by the Mini-Mental State Examination (MMSE). • Exercise capacity • Structural changes of the heart assessed by echocardiography and cardiac MRI (only for EFFORT-2 patients) • Biomarkers • Blood osmolarity and copeptin • Changes in HF symptoms • Changes in whole-body composition Assessment of safety: AEs, AEs of special interest and SAEs, laboratory parameters, heart rate and blood pressure.;Timepoint(s) of evaluation of this end point: Month 6 and over the time | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Freiburg
Outcome results
None listed