Trial intelligence / Profile preview

Empagliflozin in HFpEF and Type 2 Diabetes

NCT03753087Phase 4

Key facts

Status
Completed
Start
Jan 2019
Primary completion
Dec 2021
Countries
1
Modality
Small Molecules
Conditions
heart failure with preserved ejection fraction (HFpEF)type 2 diabetes mellitus (T2DM)
01

Overview

Phase 4, randomised, open-label trial of empagliflozin in heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (T2DM). Started Jan 2019; status: completed.

02

Design

Study design
RandomizedOpen-label
03

Who it enrols

Patients aged 45-80 with Type 2 Diabetes (HbA1c 6.5-10%) and HFpEF (LVEF >= 50%, diastolic dysfunction). Excludes NYHA IV, eGFR < 30, and recent CV events.

04

Registry description

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.

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