drugset / Trial / NCT03128528
Analysing the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
RandomizedParallel-groupTriple-blindTreatment
Summary
The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.
Timeline
- Start
- 2017-07-01
- Primary completion
- 2020-01-31
- Completion
- 2020-04-30
Publications
- Background Striepe K, Jumar A, Ott C, Karg MV, Schneider MP, Kannenkeril D, Schmieder RE. Effects of the Selective Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin on Vascular Function and Central Hemodynamics in Patients With Type 2 Diabetes Mellitus. Circulation. 2017 Sep 19;136(12):1167-1169. doi: 10.1161/CIRCULATIONAHA.117.029529. No abstract available.
- Bytyqi V, Kannenkeril D, Kolwelter J, Linz P, Bosch A, Striepe K, Karg MV, Nagel AM, Uder M, Schiffer M, Achenbach S, Schmieder RE. Short- and mid-term effects of empagliflozin on sodium balance and fluid regulation in chronic heart failure. Eur J Heart Fail. 2025 Dec;27(12):3134-3141. doi: 10.1002/ejhf.70078. Epub 2025 Nov 4.
- Kolwelter J, Kannenkeril D, Linz P, Jung S, Nagel AM, Bosch A, Ott C, Bramlage P, Noh L, Schiffer M, Uder M, Achenbach S, Schmieder RE. The SGLT2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure: results from a placebo-controlled randomised trial. Clin Res Cardiol. 2023 Jan;112(1):134-144. doi: 10.1007/s00392-022-02119-7. Epub 2022 Oct 26.
- Pietschner R, Kolwelter J, Bosch A, Striepe K, Jung S, Kannenkeril D, Ott C, Schiffer M, Achenbach S, Schmieder RE. Effect of empagliflozin on ketone bodies in patients with stable chronic heart failure. Cardiovasc Diabetol. 2021 Nov 9;20(1):219. doi: 10.1186/s12933-021-01410-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Empagliflozin | Small molecule | 10 mg | Oral |