University of Massachusetts Medical School Faculty Publications

UMMS Affiliation

Department of Medicine, Division of Cardiovascular Medicine; Department of Quantitative Health Sciences; Department of Emergency Medicine; Meyers Primary Care Institute

Date

10-9-2015

Document Type

Article

Disciplines

Biomedical Devices and Instrumentation | Cardiology | Cardiovascular Diseases | Diagnosis | Health Services Administration | Investigative Techniques

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.

CONCLUSION: 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.

TRIAL REGISTRATION: Clinicaltrials.gov NCT01877369: https://clinicaltrials.gov/ct2/show/NCT01877369 (Archived by WebCite at http://www.webcitation.org/6bDYl0dGy).

Rights and Permissions

Citation: JMIR Res Protoc. 2015 Oct 9;4(4):e121. doi: 10.2196/resprot.4899. Link to article on publisher's site

Comments

Copyright ©Silviu Dovancescu, Jane S. Saczynski, Chad E. Darling, Jarno Riistama, Fatima Sert Kuniyoshi, Theo Meyer, Robert Goldberg, David D. McManus. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.10.2015. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication onhttp://www.researchprotocols.org, as well as this copyright and license information must be included.

Related Resources

Link to Article in PubMed

Keywords

acute decompensated heart failure, rehospitalization, remote monitoring, transthoracic bioimpedance, wearable fluid accumulation vest

PubMed ID

26453479

 
 

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