title: Detecting Heart Failure Decompensation by Measuring Transthoracic Bioimpedance in the Outpatient Setting: Rationale and Design of the SENTINEL-HF Study.
abstract: BACKGROUND
  Recurrent hospital admissions are common among patients admitted for acute decompensated heart failure (ADHF), but identification of patients at risk for rehospitalization remains challenging. Contemporary heart failure (HF) management programs have shown modest ability to reduce readmissions, partly because they monitor signs or symptoms of HF worsening that appear late during decompensation. Detecting early stages of HF decompensation might allow for immediate application of effective HF therapies, thereby potentially reducing HF readmissions. One of the earliest indicators of HF decompensation is intrathoracic fluid accumulation, which can be assessed using transthoracic bioimpedance.
  
  
  OBJECTIVE
  The SENTINEL-HF study is a prospective observational study designed to test a novel, wearable HF monitoring system as a predictor of HF decompensation among patients discharged after hospitalization for ADHF.
  
  
  METHODS
  SENTINEL-HF tests the hypothesis that a decline in transthoracic bioimpedance, as assessed daily with the Philips fluid accumulation vest (FAV) and transmitted using a mobile phone, is associated with HF worsening and rehospitalization. According to pre-specified power calculations, 180 patients admitted with ADHF are enrolled. Participants transmit daily self-assessments using the FAV-mobile phone dyad for 45 days post-discharge. The primary predictor is the deviation of transthoracic bioimpedance for 3 consecutive days from a patient-specific normal variability range. The ADHF detection algorithm is evaluated in relation with a composite outcome of HF readmission, diuretic up-titration, and self-reported HF worsening (Kansas City Cardiomyopathy Questionnaire) during a 90-day follow-up period. Here, we provide the details and rationale of SENTINEL-HF.
  
  
  RESULTS
  Enrollment in the SENTINEL-HF study is complete and the 90-days follow-up is currently under way. Once data collection is complete, the study dataset will be used to evaluate our ADHF detection algorithm and the results submitted for publication.
  
  
  CONCLUSIONS
  SENTINEL-HF emerged from our long-term vision that advanced home monitoring technology can improve the management of chronic HF by extending clinical care into patients' homes. Monitoring transthoracic bioimpedance with the FAV may identify patients at risk of recurrent HF decompensation and enable timely preventive measures.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01877369: https://clinicaltrials.gov/ct2/show/NCT01877369 (Archived by WebCite at http://www.webcitation.org/6bDYl0dGy).
authors.affiliation: Philips Research, Eindhoven, Netherlands. silviu.dovancescu@philips.com.
authors.forename: Silviu
authors.identifier: http://orcid.org/0000-0002-3828-4921
authors.initials: S
authors.lastname: Dovancescu
authors.forename: Jane S
authors.identifier: http://orcid.org/0000-0002-6479-1150
authors.initials: JS
authors.lastname: Saczynski
authors.forename: Chad E
authors.identifier: http://orcid.org/0000-0003-2701-4384
authors.initials: CE
authors.lastname: Darling
authors.forename: Jarno
authors.identifier: http://orcid.org/0000-0002-5249-6648
authors.initials: J
authors.lastname: Riistama
authors.forename: Fatima
authors.identifier: http://orcid.org/0000-0001-7644-7384
authors.initials: F
authors.lastname: Sert Kuniyoshi
authors.forename: Theo
authors.identifier: http://orcid.org/0000-0002-7068-1513
authors.initials: T
authors.lastname: Meyer
authors.forename: Robert
authors.identifier: http://orcid.org/0000-0001-7705-7740
authors.initials: R
authors.lastname: Goldberg
authors.forename: David D
authors.identifier: http://orcid.org/0000-0002-9343-6203
authors.initials: DD
authors.lastname: McManus
keywords: acute decompensated heart failure; rehospitalization; remote monitoring; transthoracic bioimpedance; wearable fluid accumulation vest