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

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ClinicalTrials.gov Identifier: NCT02448342
Recruitment Status : Terminated
First Posted : May 19, 2015
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Remote Dielectric Sensing (ReDS) Wearable System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. The rate of recurrent events of HF readmissions [ Time Frame: Entire follow-up period (Expected average of 6.5 months) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Proportions of total days lost to hospitalization due to HF events [ Time Frame: Entire follow-up period (Expected average of 6.5 months) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 exclusion criteria is not met.
  4. Diagnosis of Severe Pulmonary Hypertension.
  5. STEMI and or CABG within 30 days of screening visit. Note: Type 2 MI due to ADHF is not an exclusion.
  6. Chronic renal failure with CrCl<25mL/min, as calculated by the Cockcroft-Gault formula.
  7. Chronic home IV therapy or cardiac inotropes or diuretics
  8. Physical deformity in the thorax area or lesion that may prevent proper vest application or adjustment (Severe scoliosis/ sensitive sternotomy lesion etc.).
  9. 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).
  10. Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
  11. 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.
  12. 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.
  13. 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.
  14. Severe disease / conditions with life expectancy <6 months according to investigator's assessment.
  15. Patient is enrolled in another interventional study with permission of study manager (observational or registries are not excluded).
  16. Patient HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, Weight scale, BNP or bioimpedance).
  17. Prisoners and ward of the state

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448342


  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-0007
United States, California
Cedars Sinai
Hollywood, California, United States, 90048
Scripps Memorial Hospital La Jolla
La Jolla, California, United States, 92037
Scripps Mercy Hospital San Diego
San Diego, California, United States, 92103
UCSF Medical Center, Parnassus
San Francisco, California, United States, 94143
Pacific Heart Institute
Santa Monica, California, United States, 90404
United States, Connecticut
Yale University Medical Center
New Haven, Connecticut, United States, 06519
United States, District of Columbia
MedStar Heart and Vascular Institute
Washington, District of Columbia, United States, 20010
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Encore Research Group
Jacksonville, Florida, United States, 32207
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Northshore University HealthSystem
Evanston, Illinois, United States, 60201
Advanced Heart Care Group
Fairview Heights, Illinois, United States, 62208
Edward Heart Hospital
Naperville, Illinois, United States, 60540
Prairie Heart Institute / St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Kentucky
St Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
St. Louis Heart and Vascular
Saint Louis, Missouri, United States, 63136
United States, Nebraska
Bryan Heart
Lincoln, Nebraska, United States, 68506
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Hospital
New Hyde Park, New York, United States, 11040
Mount Sinai Medical Center
New York, New York, United States, 10029
Weil Cornell Medical Center
New York, New York, United States, 10065
Lenox Hill Hospital
New York, New York, United States, 10075
United States, Ohio
Suma Health Services
Akron, Ohio, United States, 44304
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210-1252
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210-1252
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Lancaster General Health Hospital
Lancaster, Pennsylvania, United States, 17603
Drexel University Medical Center
Philadelphia, Pennsylvania, United States, 19102
VA Pittsburgh Health System
Pittsburgh, Pennsylvania, United States, 15240
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 17822
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States, 17043
United States, Tennessee
Centennial Medical Center - Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cardiovascular Specialties
Midlothian, Virginia, United States, 23112
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23229
Sponsors and Collaborators
Sensible Medical Innovations Ltd.
Investigators
Principal Investigator: William Abraham, MD Ohio State University
Study Director: Aharon (Ronnie) Abbo, MD Sensible Medical Innovations Ltd.

Additional Information:
Publications:
Responsible Party: Sensible Medical Innovations Ltd.
ClinicalTrials.gov Identifier: NCT02448342     History of Changes
Other Study ID Numbers: CL-00100-P
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: August 2017

Keywords provided by Sensible Medical Innovations Ltd.:
Heart Failure
Remote Patient Monitoring
Non Invasive Lung Fluid Status Monitor

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases