DOI QR코드

DOI QR Code

Home Bioelectrical Impedance Analysis Management System in Patients With Heart Failure: Rationale and Study Design

  • Min Gyu Kong (Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine) ;
  • Inki Moon (Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine) ;
  • Hye-Sun Seo (Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine) ;
  • Jon Suh (Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine) ;
  • Jah Yeon Choi (Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine) ;
  • Jin Oh Na (Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine) ;
  • Eung Ju Kim (Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine)
  • 투고 : 2023.03.24
  • 심사 : 2023.08.11
  • 발행 : 2024.01.31

초록

Body fluid monitoring and management are essential to control dyspnea and prevent re-hospitalization in patients with chronic heart failure (HF). There are several methods to estimate and monitor patient's volume status, such as symptoms, signs, body weight, and implantable devices. However, these methods might be difficult to use for reasons that are slow to reflect body water change, inaccurate in specific patients' condition, or invasive. Bioelectrical impedance analysis (BIA) is a novel method for body water monitoring in patients with HF, and the value in prognosis has been proven in previous studies. We aim to determine the efficacy and safety of home BIA body water monitoring-guided HF treatment in patients with chronic HF. This multi-center, open-label, randomized control trial will enroll patients with HF who are taking loop diuretics. The home BIA group patients will be monitored for body water using a home BIA device and receive messages regarding their edema status and direction of additional diuretics usage or behavioral changes through the linked application system once weekly. The control group patients will receive the usual HF management. The primary endpoint is the change in N-terminal prohormone of brain natriuretic peptide levels from baseline after 12 weeks. This trial will provide crucial evidence for patient management with a novel home BIA body water monitoring system in patients with HF.

키워드

참고문헌

  1. Gheorghiade M, De Luca L, Fonarow GC, Filippatos G, Metra M, Francis GS. Pathophysiologic targets in the early phase of acute heart failure syndromes. Am J Cardiol 2005;96:11G-17G.
  2. Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol 2009;53:557-73.
  3. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J 2007;154:260-6.
  4. Sato M, Inai K, Shimizu M, Sugiyama H, Nakanishi T. Bioelectrical impedance analysis in the management of heart failure in adult patients with congenital heart disease. Congenit Heart Dis 2019;14:167-75.
  5. Zink MD, Konig F, Weyer S, et al. Segmental bioelectrical impedance spectroscopy to monitor fluid status in heart failure. Sci Rep 2020;10:3577.
  6. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016;37:2129-200.
  7. McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2021;42:3599-726.
  8. Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet 2021;398:991-1001.
  9. Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Curr Heart Fail Rep 2009;6:287-92.
  10. Di Somma S, Navarin S, Giordano S, et al. The emerging role of biomarkers and bio-impedance in evaluating hydration status in patients with acute heart failure. Clin Chem Lab Med 2012;50:2093-105.
  11. Bedogni G, Malavolti M, Severi S, et al. Accuracy of an eight-point tactile-electrode impedance method in the assessment of total body water. Eur J Clin Nutr 2002;56:1143-8.
  12. Earthman CP. Body composition tools for assessment of adult malnutrition at the bedside: a tutorial on research considerations and clinical applications. JPEN J Parenter Enteral Nutr 2015;39:787-822.
  13. Deurenberg P, Tagliabue A, Schouten FJ. Multi-frequency impedance for the prediction of extracellular water and total body water. Br J Nutr 1995;73:349-58.
  14. de Lorenzo A, Barra PF, Sasso GF, Battistini NC, Deurenberg P. Body impedance measurements during dialysis. Eur J Clin Nutr 1991;45:321-5.
  15. Kataoka H. A new monitoring method for the estimation of body fluid status by digital weight scale incorporating bioelectrical impedance analyzer in definite heart failure patients. J Card Fail 2009;15:410-8.
  16. Summers RL, Shoemaker WC, Peacock WF, Ander DS, Coleman TG. Bench to bedside: electrophysiologic and clinical principles of noninvasive hemodynamic monitoring using impedance cardiography. Acad Emerg Med 2003;10:669-80.
  17. Kyle UG, Bosaeus I, De Lorenzo AD, et al. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr 2004;23:1226-43.
  18. Parrinello G, Paterna S, Di Pasquale P, et al. The usefulness of bioelectrical impedance analysis in differentiating dyspnea due to decompensated heart failure. J Card Fail 2008;14:676-86.
  19. Castillo Martinez L, Colin Ramirez E, Orea Tejeda A, et al. Bioelectrical impedance and strength measurements in patients with heart failure: comparison with functional class. Nutrition 2007;23:412-8.
  20. Woodrow G, Devine Y, Cullen M, Lindley E. Application of bioelectrical impedance to clinical assessment of body composition in peritoneal dialysis. Perit Dial Int 2007;27:496-502.
  21. Liu MH, Wang CH, Huang YY, et al. Edema index established by a segmental multifrequency bioelectrical impedance analysis provides prognostic value in acute heart failure. J Cardiovasc Med (Hagerstown) 2012;13:299-306.
  22. Liu MH, Wang CH, Huang YY, et al. Edema index-guided disease management improves 6-month outcomes of patients with acute heart failure. Int Heart J 2012;53:11-7.
  23. Felker GM, Anstrom KJ, Adams KF, et al. Effect of natriuretic peptide-guided therapy on hospitalization or cardiovascular mortality in high-risk patients with heart failure and reduced ejection fraction: a randomized clinical trial. JAMA 2017;318:713-20.
  24. McLellan J, Bankhead CR, Oke JL, Hobbs FD, Taylor CJ, Perera R. Natriuretic peptide-guided treatment for heart failure: a systematic review and meta-analysis. BMJ Evid Based Med 2020;25:33-7.
  25. Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 2016;387:453-61.
  26. Bhatia A, Maddox TM. Remote patient monitoring in heart failure: factors for clinical efficacy. Int J Heart Fail 2020;3:31-50.