Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2) inhibitors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anton Borisov; National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Collaborator: Ministry of Health of the Russian Federation
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. Males and females aged 45 to 80 years at screening

2. Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks

3. HbA1c ≥ 6,5% and ≤ 10% at screening

4. Diagnosis of HFpEF which includes:

• Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)

• Ejection fraction ≥ 50% (by Simpson)

• Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) [according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016]

5. Signed and dated informed consent

Exclusion Criteria:

1. Pretreatment with empagliflozin or other SGLT-2 inhibitor within the last 2 months

2. Type-1 diabetes mellitus

3. NYHA classification IV or acute decompensated heart failure at screening

4. Impaired renal function, defined as eGFR <30 ml/min/1.73 m² of body-surface-area (CKD-EPI)

5. Systolic blood pressure > 180 mmHg or < 90 mmHg

6. Permanent atrial flutter or atrial fibrillation

7. Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc.

8. Anemia (Hb < 100 g/l)

9. Myocardial infarction, coronary artery bypass graft surgery within the last 3 months

10. Stroke or TIA within the last 3 months

11. Indications of liver disease

12. Acute genital infection or urinary tract infection

13. Pregnancy

14. Additional exclusion criteria may apply