SMILE™: Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients

Sponsor

Sensible Medical Innovations Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02448342

Collaborator

(none)

380

Enrollment

Locations

Arms

Actual Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Remote Dielectric Sensing (ReDS) Wearable System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Sensible Medical Innovations (Noninvasive) Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients- a Randomized Controlled Study

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReDS Guided Treatment 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 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. Other Names: ReDS Wearable Vest
Active Comparator: Standard of Care- Control arm 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. Other Names: ReDS Wearable Vest

Arm

Intervention/Treatment

Experimental: ReDS Guided Treatment

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

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.

Other Names:

ReDS

Wearable Vest

Active Comparator: Standard of Care- Control arm

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

Other Names:

ReDS

Wearable Vest

Outcome Measures

Primary Outcome Measures

The rate of recurrent events of HF readmissions [Entire follow-up period (Expected average of 6.5 months)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

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 Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294-0007
2	Cedars Sinai	Hollywood	California	United States	90048
3	Scripps Memorial Hospital La Jolla	La Jolla	California	United States	92037
4	Scripps Mercy Hospital San Diego	San Diego	California	United States	92103
5	UCSF Medical Center, Parnassus	San Francisco	California	United States	94143
6	Pacific Heart Institute	Santa Monica	California	United States	90404
7	Yale University Medical Center	New Haven	Connecticut	United States	06519
8	MedStar Heart and Vascular Institute	Washington	District of Columbia	United States	20010
9	Washington DC VA Medical Center	Washington	District of Columbia	United States	20422
10	Memorial Regional Hospital	Hollywood	Florida	United States	33021
11	Encore Research Group	Jacksonville	Florida	United States	32207
12	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
13	University of Chicago	Chicago	Illinois	United States	60637
14	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
15	Northshore University HealthSystem	Evanston	Illinois	United States	60201
16	Advanced Heart Care Group	Fairview Heights	Illinois	United States	62208
17	Edward Heart Hospital	Naperville	Illinois	United States	60540
18	Prairie Heart Institute / St. John's Hospital	Springfield	Illinois	United States	62701
19	St Elizabeth Healthcare	Edgewood	Kentucky	United States	41017
20	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
21	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
22	St. Louis Heart and Vascular	Saint Louis	Missouri	United States	63136
23	Bryan Heart	Lincoln	Nebraska	United States	68506
24	North Shore University Hospital	Manhasset	New York	United States	11030
25	Long Island Jewish Hospital	New Hyde Park	New York	United States	11040
26	Mount Sinai Medical Center	New York	New York	United States	10029
27	Weil Cornell Medical Center	New York	New York	United States	10065
28	Lenox Hill Hospital	New York	New York	United States	10075
29	Suma Health Services	Akron	Ohio	United States	44304
30	Cleveland Clinic	Cleveland	Ohio	United States	44195
31	Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210-1252
32	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210-1252
33	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
34	Lancaster General Health Hospital	Lancaster	Pennsylvania	United States	17603
35	Drexel University Medical Center	Philadelphia	Pennsylvania	United States	19102
36	VA Pittsburgh Health System	Pittsburgh	Pennsylvania	United States	15240
37	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	17822
38	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania	United States	17043
39	Centennial Medical Center - Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
40	Virginia Cardiovascular Specialties	Midlothian	Virginia	United States	23112
41	Henrico Doctors' Hospital	Richmond	Virginia	United States	23229