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

Sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study ID
NCT03753087
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    10 mg tablet
  • Standard care — OTHER
    Standard care with no SGLT-2 inhibitors

Study Details

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.

Key Dates

Start date
Jan 16, 2019
Status verified
Jan 2022
Primary completion
Dec 16, 2021
Completion
Jan 10, 2022

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily
  • Active Comparator: Control
    Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors

Primary Outcome Measure

Change in 6-minute walking distance (6MWD) [ Time Frame: 24 weeks ]

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