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

December 28, 2017 updated by: Sensible Medical Innovations Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of recurrent events of HF readmissions
Time Frame: Entire follow-up period (Expected average of 6.5 months)
Entire follow-up period (Expected average of 6.5 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
time to event (from time of discharge until the date of first event of HF readmissions, assessed up to 6.5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensible Medical Innovations Ltd.

Investigators

  • Study Director: Aharon (Ronnie) Abbo, MD, Sensible Medical Innovations Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-00100-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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