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In-home wearable system to detect early-stage decompensation in heart failure patients

Award Number: R01HL165009
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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In-home wearable system to detect early-stage decompensation in heart failure patients - Project Summary/Abstract In the U.S., heart failure (HF) affects over 6 million people and is one of the most common causes of hospitalization. New technologies are needed to enable in-home monitoring to guide and treatment changes for patients at risk of developing Acute Decompensated HF (ADHF). Early detection of decompensated HF often relies on monitoring weight gain, but weight alone does not accurately gauge the fluid accumulation that predicts worsening of HF. A device that can measure vital signs (including heart rates and respiratory rates), intrathoracic fluid status (using thoracic bioimpedance), and heart rhythm, may allow for more accurate identification of the early stages of acute decompensation in chronic HF patients. The multidisciplinary team from the University of Massachusetts (UMass) Amherst, UMass Medical School, and the University of Connecticut proposes to develop a novel device for in-home monitoring of HF patients who are at risk of decompensation. The central hypothesis is that an innovative bioimpedance and electrocardiogram monitor with re-usable, non-wetted, and flexible bioimpedance electrodes embedded in a wearable vest, used in conjunction with a smartphone and cloud server, will continuously collect, transmit, and monitor key physiologic data. Devices running decision-support algorithms will analyze these data to identify patients with an emergent HF decompensation that may be mitigated with prompt medical attention. A Bioimpedance and Electrocardiogram Device (BED) attached to the back of the vest collects 5 minutes of data once a day from the vest electrodes, calculates bioimpedance, and has fault- tolerant assessment circuits to enable reliable data collection. Collected data consisting of heart rhythm, some vital signs, intrathoracic fluid accumulation measurements, and information about the data reliability will be sent to a smartphone from the BED via Bluetooth-Low-Energy (BLE) wireless communication. This data, together with the patient's weight, and symptoms and signs noted in the application, such as shortness of breath or lower leg swelling, will be recorded by patients and be sent to a cloud server via 4/5G/WiFi mobile networks. These data will be used to develop a robust clinical decision support algorithm that accurately detects early ADHF. This project aims to: A1.1) develop a wearable vest with reusable carbon-black and polydimethylsiloxane (CB/PDMS) electrodes that capture 3-channel bioimpedance and electrocardiogram data; A1.2) develop a BED with fault- tolerant circuit; A1.3) develop a smartphone application, to include a machine learning algorithm that uses the collected physiological information for autonomous early ADHF detection; A2.1) establish a cloud infrastructure that allows for the collection of the aforementioned data from the in-home setting along with associated data reliability monitoring; and A2.2) evaluate the performance and usability of the system in a prospectively recruited cohort study of patients with known HF. The clinical study will target a diverse HF population that are at high risk for ADHF. A successful project will result in the design, testing, and clinical evaluation of a prototype telehealth monitoring system to collect real-time data about cardiac risk factors for people with HF.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $680,070 )
2025	2025	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Cardiovascular Diseases Research	000	4	7/15/2025	NON-COMPETING CONTINUATION	$680,070
														Subtotal = $680,070

Issue Date FY: 2024 ( Subtotal = $690,399 )
2024	2024	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Cardiovascular Diseases Research	000	3	7/1/2024	NON-COMPETING CONTINUATION	$690,399
														Subtotal = $690,399

Issue Date FY: 2023 ( Subtotal = $418,834 )
2023	2023	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Cardiovascular Diseases Research	000	2	6/26/2023	NON-COMPETING CONTINUATION	$418,834
														Subtotal = $418,834

Issue Date FY: 2022 ( Subtotal = $479,359 )
2022	2022	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Cardiovascular Diseases Research	000	1	8/4/2022	NEW	$479,359
														Subtotal = $479,359

Grand Total All Awards = $2,268,662

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In-home wearable system to detect early-stage decompensation in heart failure patients

Award Number: R01HL165009

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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