drugset / Trial / NCT05042973
The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
Phase 2
Completed
165 enrolled
Jacob Moller
Danish Heart Foundation · collabHerlev and Gentofte Hospital · collabHillerod Hospital, Denmark · collabRigshospitalet, Denmark · collabUniversity Hospital Bispebjerg and Frederiksberg · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed. The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.
Timeline
- Start
- 2021-09-02
- Primary completion
- 2025-01-16
- Completion
- 2025-01-23
Publications
- Andersen CF, Larsen JH, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Knop FK, Forman JL, Davidovski FS, Kober L, Sabaratnam R, Hojlund K, Schou M, Moller JE, Jensen J. The effect of empagliflozin on inflammation in patients with overweight or obesity and risk of heart failure: a substudy from the Empire Prevent Metabolic trial. Cardiovasc Diabetol. 2026 Jun 12. doi: 10.1186/s12933-026-03216-x. Online ahead of print.
- Andersen CF, Larsen JH, Jensen J, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Gustafsson F, Knop FK, Forman JL, Davidovski FS, Jensen LT, Hojlund K, Kober L, Antonsen L, Poulsen MK, Schou M, Moller JE. Empagliflozin to elderly and obese patients with increased risk of developing heart failure: Study protocol for the Empire Prevent trial program. Am Heart J. 2024 May;271:84-96. doi: 10.1016/j.ahj.2024.02.005. Epub 2024 Feb 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Empagliflozin | Small molecule | 10 mg | — |