a study on Heart Failure
Multi center, randomized controlled study, to determine if a significant decrease in the rate of heart failure re-hospitalizations occurs during a follow-up period when - ReDS guided treatment is used as an adjunct to standard of care.
Sensible Medical Innovations (Noninvasive) Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients- a Randomized Controlled Study
The study is designed as a prospective, randomized, controlled, multi-center trial. Patients will be enrolled during an index hospitalization for Acutely decompensated Heart Failure (ADHF) and will be followed for a minimum of 3 months or a maximum of 9 months (until the last patient has completed the 3- month follow-up). Patients will be blinded to ReDS readings values.
Recruitment will take place either during a heart failure hospitalization (see acceptance criteria below) or within 10 days after discharge from a qualifying heart failure hospitalization.
The Remote Dielectric Sensing (ReDS) device provides noninvasive measurement of lung fluid content. It comprises a wearable vest with embedded sensors and a bedside console. A measurement reading is provided within 90sec. Results are shared with the treating physician via a secured web portal.
Study objective is to determine if a significant decrease in the rate of heart failure re-hospitalizations occurs during the entire follow-up period when ReDS guided treatment is used as an adjunct to standard of care (SOC).
Patients will be randomized between two groups before hospital discharge to: ReDS with SOC vs. SOC.
Patient that are randomized to the treatment arm will perform daily ReDS measurement at home. Treating physician will follow up on patients' measurements through a secured dedicated web site. Notification messages will be automatically sent by the system to the physician if certain thresholds are crossed (thresholds are physician adjustable). Medications will be adjusted according to defined guidelines.
Patients that are randomized to the control arm will be followed up and medically managed according to standard of care guidelines.
Both arms scheduled clinical visits and phone follow up:
Heart Failure Remote Patient Monitoring Non Invasive Lung Fluid Status Monitor
For people ages 21 years and up
Main Inclusion Criteria:
BNP ≥ 350 pg/ml (NT pro BNP> 1400 pg/ml) at enrollment (within 24h) and/or ≥750 pg/ml any time during the hospital stay (NT-pro BNP>3000 pg/ml).
Note that if a patient is enrolled during a clinic visit rather than during a hospitalization, then the BNP from the index admission is referenced.
Main Exclusion Criteria:
Patient's habitus out of range due to one or more of the following:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02448342.
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