Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients
- Conditions
- Heart Failure
- Interventions
- Device: Remote Dielectric Sensing (ReDS) Wearable System
- Registration Number
- NCT02448342
- Lead Sponsor
- Sensible Medical Innovations Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 380
- Patient has signed informed consent and authorization to use and disclose health information.
- Patient's physical condition enables him to sit up and lay down with minimal assistance.
- Diagnosis of HF, with preserved or reduced LVEF, was made at least 30 days prior to enrollment.
- 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).
- 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.
- 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
-
Patient has had a cardiac transplantation or VAD implantation.
-
CRT implantation within 90 days prior to screening or planned implantation during study duration.
-
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 exclusion criteria is not met.
-
Diagnosis of Severe Pulmonary Hypertension.
-
STEMI and or CABG within 30 days of screening visit. Note: Type 2 MI due to ADHF is not an exclusion.
-
Chronic renal failure with CrCl<25mL/min, as calculated by the Cockcroft-Gault formula.
-
Chronic home IV therapy or cardiac inotropes or diuretics
-
Physical deformity in the thorax area or lesion that may prevent proper vest application or adjustment (Severe scoliosis/ sensitive sternotomy lesion etc.).
-
Illness/ Condition which may be aggravated or cause significant discomfort by the application of the vest (Rib fractures, with or without flail chest, Severe Osteoporosis).
-
Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
-
Patient's habitus out of range due to one or more of the following:
- Height less than 155cm or higher than 195cm (5.1; 6.4 feet respectively).
- BMI of less than 22 or more than 36. In case of BMI between 36-38, if the measured vest ruler is not >=4, the exclusion criteria is met.
-
Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (Dextrocardia, Lung Carcinoma etc.) including pacemaker box on the right side of the chest.
-
Severe COPD, defined as chronic and continuous home use of O2 (O2 dependancy) and/ or oral steroids. Continuous is defined as 24hours a day, every day.
-
Severe disease / conditions with life expectancy <6 months according to investigator's assessment.
-
Patient is enrolled in another interventional study with permission of study manager (observational or registries are not excluded).
-
Patient HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, Weight scale, BNP or bioimpedance).
-
Prisoners and ward of the state
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ReDS Guided Treatment Remote Dielectric Sensing (ReDS) Wearable System 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. Standard of Care- Control arm Remote Dielectric Sensing (ReDS) Wearable System After discharge from hospital, patient will be followed up and medically managed according to standard of care guidelines.
- Primary Outcome Measures
Name Time Method The rate of recurrent events of HF readmissions Entire follow-up period (Expected average of 6.5 months)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (41)
Drexel University Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Scripps Mercy Hospital San Diego
🇺🇸San Diego, California, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Cedars Sinai
🇺🇸Hollywood, California, United States
Northshore University HealthSystem
🇺🇸Evanston, Illinois, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Elmhurst Memorial Hospital
🇺🇸Elmhurst, Illinois, United States
Long Island Jewish Hospital
🇺🇸New Hyde Park, New York, United States
Suma Health Services
🇺🇸Akron, Ohio, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
UCSF Medical Center, Parnassus
🇺🇸San Francisco, California, United States
Centennial Medical Center - Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Edward Heart Hospital
🇺🇸Naperville, Illinois, United States
Washington DC VA Medical Center
🇺🇸Washington, District of Columbia, United States
MedStar Heart and Vascular Institute
🇺🇸Washington, District of Columbia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
St Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Advanced Heart Care Group
🇺🇸Fairview Heights, Illinois, United States
St. Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Weil Cornell Medical Center
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Lancaster General Health Hospital
🇺🇸Lancaster, Pennsylvania, United States
Virginia Cardiovascular Specialties
🇺🇸Midlothian, Virginia, United States
Encore Research Group
🇺🇸Jacksonville, Florida, United States
VA Pittsburgh Health System
🇺🇸Pittsburgh, Pennsylvania, United States
Prairie Heart Institute / St. John's Hospital
🇺🇸Springfield, Illinois, United States
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Yale University Medical Center
🇺🇸New Haven, Connecticut, United States
Henrico Doctors' Hospital
🇺🇸Richmond, Virginia, United States