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

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Status and phase: Completed; Phase 4

Conditions: Heart Failure, Diastolic; Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03753087

2018-9-25

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Empagliflozin

Experimental group

Description:

Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily

Treatment:

Drug: Empagliflozin

Control

Active Comparator group

Description:

Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors

Treatment:

Other: Standard care