NCT03753087

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

A Phase 4, Single-center, Randomized, Parallel Group Study to Assess 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Other Government
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Empagliflozin	10 mg tablet
OTHER	Standard care	Standard care with no SGLT-2 inhibitors

Timeline

• Start date: 2019-01-16
• Primary completion: 2021-12-16
• Completion: 2022-01-10
• First posted: 2018-11-26
• Last updated: 2022-01-11

Locations

1 site across 1 country: Russia