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

NCT ID: NCT03753087

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2022-01-10

Brief 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.

Conditions

Heart Failure, Diastolic; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empagliflozin

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

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

10 mg tablet

Control

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

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Standard care with no SGLT-2 inhibitors

Interventions

Empagliflozin

10 mg tablet

Intervention Type: DRUG

Standard care

Standard care with no SGLT-2 inhibitors

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Russian Federation

OTHER_GOV

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anton Borisov

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anton Borisov, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Cardiology

Locations

National Medical Research Center for Cardiology

Moscow, , Russia

Countries

Russia

References

Ovchinnikov A, Potekhina A, Filatova A, Svirida O, Zherebchikova K, Ageev F, Belyavskiy E. Effects of empagliflozin on functional capacity, LV filling pressure, and cardiac reserves in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction: a randomized controlled open-label trial. Cardiovasc Diabetol. 2025 May 9;24(1):196. doi: 10.1186/s12933-025-02756-y.

Reference Type: DERIVED

PMID: 40346546 (View on PubMed)

Other Identifiers

2018-9-25

Identifier Type: -

Identifier Source: org_study_id