An interventional study of Remote Dielectric Sensing (ReDS) Wearable System in Heart Failure, sponsored by Sensible Medical Innovations Ltd.. Terminated at 41 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-12-29.
Sponsored by Sensible Medical Innovations Ltd. · Not applicable, Interventional, and Prevention
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.
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:
Study follow-up visits at 1 and 3 months. Follow-up will be continued for enrolled subjects at 6 and 9 months until the last subject has pass through the 3-month follow-up window.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 380 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Sensible Medical Innovations Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
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:
After discharge from hospital, patient will perform daily ReDS measurement. Data is automatically transmitted to the secured web portal. 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. During the study a service center will monitor and support patient adherence and investigators attending to patients' notifications.
Device: Remote Dielectric Sensing (ReDS) Wearable System
After discharge from hospital, patient will be followed up and medically managed according to standard of care guidelines.
Device: Remote Dielectric Sensing (ReDS) Wearable System
The ReDS device provides noninvasive measurement of lung fluid content. It comprises a wearable vest with embedded sensors and a bedside console, with touch-screen display. A measurement reading is provided within 90sec. Results are shared with the treating physician via a secured web portal.
Also known as: ReDS, Wearable Vest
The rate of recurrent events of HF readmissions
Time frame: Entire follow-up period (Expected average of 6.5 months)
Time from discharge until the first event of HF readmissions
Time frame: Time to event (from discharge until the date of first event of HF readmissions, assessed up to 6.5 months)
Proportions of total days lost to hospitalization due to HF events
Time frame: Entire follow-up period (Expected average of 6.5 months)
Time from discharge until all-cause mortality
Time frame: time to event (from time of discharge until the date of first event of HF readmissions, assessed up to 6.5 months)
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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