Heart Failure
Conditions
Keywords
Heart Failure, Remote Patient Monitoring, Non Invasive Lung Fluid Status Monitor
Brief summary
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.
Detailed description
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: * A follow up phone call, per current treatment guidelines, will be attempted within 2 days of hospital discharge to obtain information regarding medication reconciliation, Heart Failure (HF) symptoms and other HF management issues (e.g., dietary restrictions). * An outpatient clinic visit will be scheduled after a week of hospital discharge. * 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. * At each study follow-up visit, patients will undergo complete physical exam, vital signs, collection of readmission and standard blood tests and QOL questionnaire.
Interventions
DEVICERemote 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.
Sponsors
Sensible Medical Innovations Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Patient has signed informed consent and authorization to use and disclose health information. 2. Patient's physical condition enables him to sit up and lay down with minimal assistance. 3. Diagnosis of HF, with preserved or reduced LVEF, was made at least 30 days prior to enrollment. 4. Patients with LVEF \<40% must have been treated at least 30 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contra-indicated) and an ACE-inhibitor or ARB (unless intolerant or contra-indicated). 5. Patient is hospitalized for ADHF requiring significant alteration in heart failure treatment (i.e. diuretics or vasoactive drugs) or up to 10 days post-discharge from an ADHF admission. 6. 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
1. Patient has had a cardiac transplantation or VAD implantation. 2. CRT implantation within 90 days prior to screening or planned implantation during study duration. 3. Current or past Pulmonary Embolism in the right lung. Notes: (i) Past pulmonary emboli are defined as identified \<6 months prior to enrollment. (ii) past or current tiny, microscopic pulmonary emboli do not exclude a patient. (iii) if a ventilation-perfusion (VQ) scan shows that the lungs are clear, then the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of recurrent events of HF readmissions | Entire follow-up period (Expected average of 6.5 months) |
Secondary
| Measure | Time frame |
|---|---|
| Time from discharge until the first event of HF readmissions | 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 | Entire follow-up period (Expected average of 6.5 months) |
| Time from discharge until all-cause mortality | time to event (from time of discharge until the date of first event of HF readmissions, assessed up to 6.5 months) |
Countries
United States
Outcome results
None listed