drugset / Trial / NCT03332212
A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this trial is to assess the effect of empagliflozin on cardiac physiology and metabolism aiming to provide a scientific explanation of the underlying mechanism by which empagliflozin improves HF related outcomes in patients with chronic heart failure
Timeline
- Start
- 2018-03-01
- Primary completion
- 2020-05-21
- Completion
- 2020-05-28
Outcome
Missed primary endpoint
paper Empagliflozin treatment did not change cardiac energetics (ie, PCr/ATP) at rest in HFrEF PMID 37070436 ↗
registry Placebo Cohort A vs Empagliflozin 10mg Cohort A; p = 0.1418; Mean Difference (Final Values) -0.247 (95% CI -0.582 to 0.087) NCT03332212 ↗
registry Placebo Cohort B vs Empagliflozin 10mg Cohort B; p = 0.4650; Mean Difference (Final Values) -0.159 (95% CI -0.604 to 0.286) NCT03332212 ↗
Publications
- Hundertmark MJ, Adler A, Antoniades C, Coleman R, Griffin JL, Holman RR, Lamlum H, Lee J, Massey D, Miller JJJJ, Milton JE, Monga S, Mozes FE, Nazeer A, Raman B, Rider O, Rodgers CT, Valkovic L, Wicks E, Mahmod M, Neubauer S. Assessment of Cardiac Energy Metabolism, Function, and Physiology in Patients With Heart Failure Taking Empagliflozin: The Randomized, Controlled EMPA-VISION Trial. Circulation. 2023 May 30;147(22):1654-1669. doi: 10.1161/CIRCULATIONAHA.122.062021. Epub 2023 Apr 18.
- Hundertmark MJ, Agbaje OF, Coleman R, George JT, Grempler R, Holman RR, Lamlum H, Lee J, Milton JE, Niessen HG, Rider O, Rodgers CT, Valkovic L, Wicks E, Mahmod M, Neubauer S. Design and rationale of the EMPA-VISION trial: investigating the metabolic effects of empagliflozin in patients with heart failure. ESC Heart Fail. 2021 Aug;8(4):2580-2590. doi: 10.1002/ehf2.13406. Epub 2021 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | — |