CompletedPhase 4

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

Russia70 participantsStarted 2019-01-16

Plain-language 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.

Who can participate

Age range45 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Signed and dated informed consent

Exclusion criteria

✕. 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)

What they're measuring

Change in 6-minute walking distance (6MWD)

Timeframe: 24 weeks

Trial details

NCT IDNCT03753087

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-12-16

View on ClinicalTrials.gov More Heart Failure, Diastolic trials