Interim Results of the BYHEART Observational Study: Exogenous Phosphocreatine Effect on the Quality of life of Patients with Chronic Heart Failure
https://doi.org/10.18087/cardio.2021.7.n1649
Abstract
Aim Improvement of quality of life is one of the most important goals for the treatment of patients with chronic heart failure (CHF). This study searched for ways to increase the efficiency of CHF treatment based on parameters of quality of life in CHF patients during and after the treatment with exogenous phosphocreatine (EP).
Material and methods The effect of a single course of EP treatment on quality of life of patients with functional class (FC) II-IV CHF with reduced or mid-range left ventricular ejection fraction was studied as a part of the all-Russia prospective observational study BYHEART. The presence of FC II-IV CHF and a left ventricular ejection fraction <50 % were confirmed by results of 6-min walk test (6MWT) and findings of echocardiography after stabilization of the background therapy.
Results An interim data analysis showed that the course of EP treatment was associated with a significant improvement of quality-of-life indexes as determined by the Minnesota Living with Heart Failure Questionnaire (LHFQ) total score. These indexes significantly increased and remained at a satisfactory level for 6 mos. following completion of the treatment course. Also, the treatment significantly beneficially influenced the clinical condition of patients (heart failure severity scale), results of 6MWT, and the increase in left ventricular ejection fraction.
Conclusion The conclusions based on results of the interim analysis should be confirmed by results of the completed study. Complete results are planned to be published in 2022.
Keywords
About the Authors
S. N. TereschenkoRussian Federation
Head of the Department of Myocardial and Heart Failure Diseases , First Deputy General Director, Deputy General Director of Scientific Work, Doctor of Medical Sciences, Professor, Honored Worker of Science of the Russian Federation
N. B. Perepech
Russian Federation
Professor, Doctor of Medical Sciences Head of the Scientific, Clinical and Educational Center "Cardiology" of the Institute of High Medical Technologies, Faculty of Medicine
I. A. Cheremisina
Russian Federation
Medical Affairs Manager, PhD
V. N. Belov
Russian Federation
Head of the Department of Medical Rehabilitation
Y. A. Vollis
Russian Federation
Cardiologist
A. A. Ispiriyan
Russian Federation
Head of the cardiology department №2, Cardiologist
E. A. Gridneva
Russian Federation
Cardiologist of the highest category
A. A. Ismailova
Russian Federation
Head of the of BIT of the Cardiology Department, cardiologist, resuscitation specialist
M. N. Maltseva
Russian Federation
Cardiologist
E. H. Melnikova
Russian Federation
Cardiologist, Honored Doctor of the Russian Federation
Y N Moiseeva
Russian Federation
Cardiologist
M. I. Petrenko
Russian Federation
Head Department of Cardiology, Cardiologist, Ph.D.
M. M. Takhtamysheva
Russian Federation
Cardiologist
T. S. Titova
Russian Federation
Cardiologist
F. R. Khaidarova
Russian Federation
Cardiologist
A. N. Savenkova
Russian Federation
Cardiologist
References
1. James SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet. 2018;392(10159):1789–858. DOI: 10.1016/S0140-6736(18)32279-7
2. Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. European Journal of Heart Failure. 2020;22(8):1342–56. DOI: 10.1002/ejhf.1858
3. Tereshchenko S.N., Galyavich A.S., Uskach T.M., Ageev F.T., Arutyunov G.P., Begrambekova Yu.L. et al. 2020 Clinical practice guidelines for Chronic heart failure. Russian Journal of Cardiology. 2020;25(11):311–74. DOI: 10.15829/1560-4071-2020-4083
4. Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta‐analysis. European Journal of Heart Failure. 2019;21(11):1306–25. DOI: 10.1002/ejhf.1594
5. Mareev V.Yu., Fomin I.V., Ageev F.T., Begrambekova Yu.L., Vasyuk Yu.A., Garganeeva A.A. et al. Russian Heart Failure Society, Russian Society of Cardiology. Russian Scientific Medical Society of Internal Medicine Guidelines for Heart failure: chronic (CHF) and acute decompensated (ADHF). Diagnosis, prevention and treatment. Kardiologiia. 2018;58(6S):8–158. DOI: 10.18087/cardio.2475
6. Hoekstra T, Jaarsma T, van Veldhuisen DJ, Hillege HL, Sanderman R, Lesman-Leegte I. Quality of life and survival in patients with heart failure. European Journal of Heart Failure. 2013;15(1):94–102. DOI: 10.1093/eurjhf/hfs148
7. Mastenbroek MH, Versteeg H, Zijlstra WP, Meine M, Spertus JA, Pedersen SS. Disease-specific health status as a predictor of mortality in patients with heart failure: a systematic literature review and metaanalysis of prospective cohort studies. European Journal of Heart Failure. 2014;16(4):384–93. DOI: 10.1002/ejhf.55
8. Moradi M, Daneshi F, Behzadmehr R, Rafiemanesh H, Bouya S, Raeisi M. Quality of life of chronic heart failure patients: a systematic review and meta-analysis. Heart Failure Reviews. 2020;25(6):993–1006. DOI: 10.1007/s10741-019-09890-2
9. Strumia E, Pelliccia F, D’Ambrosio G. Creatine Phosphate: Pharmacological and Clinical Perspectives. Advances in Therapy. 2012;29(2):99–123. DOI: 10.1007/s12325-011-0091-4
10. Horjus DL, Oudman I, van Montfrans GA, Brewster LM. Creatine and creatine analogues in hypertension and cardiovascular disease. Cochrane Database of Systematic Reviews. 2011;2011(11):CD005184. DOI: 10.1002/14651858.CD005184.pub2
11. Tereshchenko S.N., Perepech N.B., Cheremisina I.A. BYHEART observational trial of assessing exogenous phosphocreatine influence on the quality of life in patients with congestive heart failure. Cardiology and Cardiovascular Surgery. 2020;13(2):168–70. DOI: 10.17116/kardio202013021168
12. LLC “Enrollme.ru”. Сlinical and observational research management system. Av. at: https://enrollme.ru/.
13. Chen X, Xin Y, Hu W, Zhao Y, Zhang Z, Zhou Y. Quality of life and outcomes in heart failure patients with ejection fractions in different ranges. PLOS ONE. 2019;14(6):e0218983. DOI: 10.1371/journal.pone.0218983
14. Bartolucci J, Verdugo FJ, González PL, Larrea RE, Abarzua E, Goset C et al. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circulation Research. 2017;121(10):1192–204. DOI: 10.1161/CIRCRESAHA.117.310712
15. Bilbao A, Escobar A, García-Perez L, Navarro G, Quirós R. The Minnesota living with heart failure questionnaire: comparison of different factor structures. Health and Quality of Life Outcomes. 2016;14:23. DOI: 10.1186/s12955-016-0425-7
16. Garin O, Herdman M, Vilagut G, Ferrer M, Ribera A, Rajmil L et al. Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures. Heart Failure Reviews. 2014;19(3):359–67. DOI: 10.1007/s10741-013-9394-7
Review
For citations:
Tereschenko S.N., Perepech N.B., Cheremisina I.A., Belov V.N., Vollis Y.A., Ispiriyan A.A., Gridneva E.A., Ismailova A.A., Maltseva M.N., Melnikova E.H., Moiseeva Y.N., Petrenko M.I., Takhtamysheva M.M., Titova T.S., Khaidarova F.R., Savenkova A.N. Interim Results of the BYHEART Observational Study: Exogenous Phosphocreatine Effect on the Quality of life of Patients with Chronic Heart Failure. Kardiologiia. 2021;61(7):22-27. (In Russ.) https://doi.org/10.18087/cardio.2021.7.n1649