Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
Summary
There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure. Phosphocreatine plays an important part in the energy heart system. The investigators have just performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and matched studies that compared phosphocreatine with placebo or standard treatment in patients with coronary artery disease or chronic heart failure or in those undergoing cardiac surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved cardiac outcomes when compared to the control group, however, the quality of the included studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to investigate whether providing phosphocreatine compared to placebo improves the myocardial protection in high-risk patients scheduled for cardiac surgery and to determine the best research endpoint for future trials.
Timeline
- Start
- 2016-06
- Primary completion
- 2021-04
- Completion
- 2021-05
Publications
- Background Horjus DL, Oudman I, van Montfrans GA, Brewster LM. Creatine and creatine analogues in hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD005184. doi: 10.1002/14651858.CD005184.pub2.
- Background Strumia E, Pelliccia F, D'Ambrosio G. Creatine phosphate: pharmacological and clinical perspectives. Adv Ther. 2012 Feb;29(2):99-123. doi: 10.1007/s12325-011-0091-4.
- Background Landoni G, Zangrillo A, Lomivorotov VV, Likhvantsev V, Ma J, De Simone F, Fominskiy E. Cardiac protection with phosphocreatine: a meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):637-46. doi: 10.1093/icvts/ivw171. Epub 2016 Jun 17.
- Lomivorotov V, Merekin D, Fominskiy E, Ponomarev D, Bogachev-Prokophiev A, Zalesov A, Cherniavsky A, Shilova A, Guvakov D, Lomivorotova L, Lembo R, Landoni G. Myocardial protection with phosphocreatine in high-risk cardiac surgery patients: a randomized trial. BMC Anesthesiol. 2023 Nov 29;23(1):389. doi: 10.1186/s12871-023-02341-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FOSFOCREATINE | Small molecule | 2 g | Intravenous |
| Subject | FOSFOCREATINE | Small molecule | 2.5 g | Intravenous |
| Subject | FOSFOCREATINE | Small molecule | 4 g | Intravenous |