drugset / Trial / NCT03541603
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Timeline
- Start
- 2018-11-14
- Primary completion
- 2020-04-07
- Completion
- 2020-04-07
Publications
- Burkhoff D, Rich S, Pollesello P, Papp Z. Levosimendan-induced venodilation is mediated by opening of potassium channels. ESC Heart Fail. 2021 Dec;8(6):4454-4464. doi: 10.1002/ehf2.13669. Epub 2021 Oct 30.
- Burkhoff D, Borlaug BA, Shah SJ, Zolty R, Tedford RJ, Thenappan T, Zamanian RT, Mazurek JA, Rich JD, Simon MA, Chung ES, Raza F, Majure DT, Lewis GD, Preston IR, Rich S. Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial. JACC Heart Fail. 2021 May;9(5):360-370. doi: 10.1016/j.jchf.2021.01.015. Epub 2021 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levosimendan | Other / unclassified | 0.075 ug/kg | Intravenous |
| Subject | Levosimendan | Other / unclassified | 0.1 ug/kg | Intravenous |