Empagliflozin and its effect on heart failure in type 2 diabetes

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 72

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 > 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
EFFORT-2
•LVEF > 45% prior to registration

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. 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
• Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) (Screening, Month 1, 3, 6, 9 and 12)<br>• Cognitive function assessed by the Mini-Mental State Examination (MMSE) (Screening, Month 1, 3, 6, 9 and 12)<br>• Cardiopulmonary exercise testing (CPET) (Screening, Month 3, 6, 9 and 12)<br>• Structural changes of the heart assessed by echocardiography and cardiac MRI (only for EFFORT-2 patients) (Screening, Month 3, 6 and 12)<br>• Biomarkers (Screening, Week 1, 2, Month 1, 3, 6, 9 and 12)<br>• Changes in total blood/plasma volume (Screening, Week 1, 2, Month 1, 3, 6, 9 and 12)<br>• Changes in heart insufficiency symptoms (continuously)<br>• Changes in whole-body composition (DEXA) (Screening, Month 1, 6 and 12)<br>

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