Status:
COMPLETED
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
Lead Sponsor:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborating Sponsors:
Ministry of Health, Russian Federation
Conditions:
Heart Failure, Diastolic
Diabetes Mellitus, Type 2
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
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....
Eligibility Criteria
Inclusion
- Males and females aged 45 to 80 years at screening
- Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
- HbA1c ≥ 6,5% and ≤ 10% at screening
- 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) \[according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016\]
- Signed and dated informed consent
Exclusion
- Pretreatment with empagliflozin or other SGLT-2 inhibitor within the last 2 months
- Type-1 diabetes mellitus
- NYHA classification IV or acute decompensated heart failure at screening
- Impaired renal function, defined as eGFR \<30 ml/min/1.73 m² of body-surface-area (CKD-EPI)
- Systolic blood pressure \> 180 mmHg or \< 90 mmHg
- Permanent atrial flutter or atrial fibrillation
- Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc.
- Anemia (Hb \< 100 g/l)
- Myocardial infarction, coronary artery bypass graft surgery within the last 3 months
- Stroke or TIA within the last 3 months
- Indications of liver disease
- Acute genital infection or urinary tract infection
- Pregnancy
- Additional exclusion criteria may apply
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03753087
Start Date
January 16 2019
End Date
January 10 2022
Last Update
January 11 2022
Active Locations (1)
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1
National Medical Research Center for Cardiology
Moscow, Russia, 121552