We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "sensible medical"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified August 2017 by Sensible Medical Innovations Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02448342
First Posted: May 19, 2015
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sensible Medical Innovations Ltd.
  Purpose
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 Intervention
Heart Failure Device: Remote Dielectric Sensing (ReDS) Wearable System

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sensible Medical Innovations Ltd.:

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

Secondary Outcome Measures:
  • 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) ]
  • Proportions of total days lost to hospitalization due to HF events [ Time Frame: 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) ]

Estimated Enrollment: 380
Actual Study Start Date: September 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Marci Mishkin (917) 403-9058 marci.m@sensible-medical.com
Contact: William Tobin (203) 895 7440 billt@ihcresearch.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294-0007
Contact: Leigh Powell, RN    205-975-9859    leigh83@uab.edu   
Principal Investigator: Deepak Acharya, MD         
United States, California
Cedars Sinai Recruiting
Hollywood, California, United States, 90048
Contact: Jeena Ca    310-385-2974    Jeena.Cha@cshs.org   
Principal Investigator: Raymond Zimmer, MD         
Sub-Investigator: Ilan Kedan, MD         
Sub-Investigator: Raj Khandwalla, MD         
Scripps Memorial Hospital La Jolla Recruiting
La Jolla, California, United States, 92037
Contact: Monique Edwards-Moble, CCRC    858-824-4168    edwards-mobley.monique@scrippshealth.org   
Contact: Janet Lawrence, RN    (858)-824-523    Lawrence.Janet@scrippshealth.org   
Principal Investigator: James Haywood, MD         
Scripps Mercy Hospital San Diego Recruiting
San Diego, California, United States, 92103
Contact: Monique Edwards-Mobley, CCRC    858-824-4168    edwards-mobley.monique@scrippshealth.org   
Principal Investigator: David SHaw, MD         
UCSF Medical Center, Parnassus Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Liviu Klein, MD         
Pacific Heart Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Crytsal Ducharme    310-829-7678    crystal.ducharme@providence.org   
Principal Investigator: Richard Wright, MD         
Sub-Investigator: Peter Pak, MD         
Sub-Investigator: Sarina Van Der Zee, MD         
Sub-Investigator: George Wu, MD         
Sub-Investigator: Nicole Weinberg, MD         
United States, Connecticut
The Hospital of Central Connecticut Withdrawn
New Britain, Connecticut, United States, 06050
Yale University Medical Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Varsha Menon       varsha.menon@yale.edu   
Contact: Medhat Abdelmessih       medhat.abdelmessih@yale.edu   
Principal Investigator: Joseph G Akar, MD         
United States, District of Columbia
MedStar Heart and Vascular Institute Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Hellina Birru    202-877-0572    hellina.t.birru@medstar.net   
Contact: Saadia Rizvi    202-877-0572    saadia.rizvi@medstar.net   
Principal Investigator: Selma Mohammed, MD         
Washington DC VA Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20422
Contact: Jacqueline Gannuscio, ACNP    202-745-8000 ext 57297      
Contact: Patricia Neblett    202-745-8000 ext 52464    patricia.neblett@va.gov   
Principal Investigator: Hans Moore, MD         
Sub-Investigator: Pamela Steele, MD         
United States, Florida
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Tamara Ward, ARNP       taward@mhs.net   
Contact: Ricardo Guedes    813-7853541    RGuedes@mhs.net   
Principal Investigator: Ioana Dumitru, MD         
Encore Research Group Recruiting
Jacksonville, Florida, United States, 32207
Contact: Jolene Wolfer    904-730-0101    jwolfer@encoredocs.com   
Principal Investigator: Michael Koren, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Morlisa Dixon       Morlisa.dixon@piedmont.org   
Principal Investigator: Kelly McCants, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Tracey Silverstein, RN       tsilvers@medicine.bsd.uchicago.edu   
Principal Investigator: Gene Kim, MD         
Elmhurst Memorial Hospital Recruiting
Elmhurst, Illinois, United States, 60126
Contact: Debra Heidenreich, RN       debra.heidenreich@advocatehealth.com   
Contact: Alice Szydlowska       alicja.szydlowska@advocatehealth.com   
Principal Investigator: Ali Valika, MD         
Northshore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Colleen Leonard, BA       cleonard@northshore.org   
Contact: Edessa David, BA       edavid2@northshore.org   
Principal Investigator: Robert Gordin, MD         
Advanced Heart Care Group Recruiting
Fairview Heights, Illinois, United States, 62208
Contact: Elizabeth Capasso-Gulve, PAC    618-222-8900    lizcapasso@yahoo.com   
Contact: Marlowe Mosley    6182228900      
Principal Investigator: John Lehman, MD         
Edward Heart Hospital Recruiting
Naperville, Illinois, United States, 60540
Contact: Sherri McCoy, RN       sherri.mccoy@advocatehealth.com   
Contact: Josilyn Klimek, RN       Josilyn.klimek@advocatehealth.com   
Principal Investigator: Maria Rosa Costanzo, MD         
Prairie Heart Institute / St. John's Hospital Terminated
Springfield, Illinois, United States, 62701
United States, Kentucky
St Elizabeth Healthcare Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Cynthia Mulcahy, RN       Cynthia.Mulcahy@stelizabeth.com   
Contact: Diane BuschJames, RN       Diane.BuschJames@stelizabeth.com   
Principal Investigator: Damodhar Suresh, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kelly Wilson, RN    612-863-6288    kelly.wilson@allina.com   
Contact: Sarah Dennis, RN    (612) 863-6288    sarah.dennis@allina.com   
Principal Investigator: Peter Eckman, MD         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Karen Haffey, RN       jnsmith@saint-lukes.org   
Contact: Jackie Smith, RN       khaffey@saint-lukes.org   
Principal Investigator: Andrew Kao, MD         
St. Louis Heart and Vascular Recruiting
Saint Louis, Missouri, United States, 63136
Contact: Julie Wilson    314-714-0911    jawilson@slhv.com   
Contact: Nicole Elmore    314-714-0911    nelmore@slhv.com   
Principal Investigator: Peter Mikolajczak, MD         
United States, Nebraska
Bryan Heart Not yet recruiting
Lincoln, Nebraska, United States, 68506
Contact: Rosalie Saalfeld    402-483-3294    rose.saalfeld@bryanheart.com   
Contact: Nicci Thompson    402-483-3290    nicci.thompson@bryanheart.com   
Principal Investigator: Steven Krueger, MD         
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Kristine McGowan, RN    516-562-2345    KMcGowan@Northwell.edu   
Contact: Natasha Phrsai, CCRC    516-562-4220    NPhrsai@northwell.edu   
Principal Investigator: Gerin Stevens, MD, PhD         
Long Island Jewish Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Kristine McGowan, RN    516-562-2345    KMcGowan@Northwell.edu   
Principal Investigator: Gerin Stevens, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Chris Surach, RN       cristina.surach@mountsinai.org   
Contact: John Donehey       John.Donehey@mountsinai.org   
Principal Investigator: Sean Pinney, MD         
Weil Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Melissa Ricketts       mdr2001@med.cornell.edu   
Contact: Abigail Donde       abl9002@nyp.org   
Principal Investigator: Evelyn Horn, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Jae Lee    212-434-3878    JLee58@northwell.edu   
Principal Investigator: Gerin Stevens, MD         
United States, Ohio
Suma Health Services Recruiting
Akron, Ohio, United States, 44304
Contact: Nadine Cuenot, RN    330-253-8195 ext 4259    cuenotn@summahealth.org   
Contact: Keri Shuman, RN    330-253-8195 ext 4246    Shumank@summahealth.org   
Principal Investigator: Wanda Staab, DNP         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Linda Kerchenski, RN       kerchel@ccf.org   
Contact: Lauren Ives, RN       ivesl@ccf.org   
Principal Investigator: Eiran Gorodeski, MD         
Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210-1252
Contact: Michelle Bright       Michelle.Bright@osumc.edu   
Contact: Sarah Stocckdale    614-292-3496    Sarah.Stockdale@osumc.edu   
Principal Investigator: Rami Kahwash, MD         
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210-1252
Contact: Michelle Bright       Michelle.Bright@osumc.edu   
Contact: Sarah Stockdale       Sarah.Stockdale@osumc.edu   
Principal Investigator: Rami Kahwash, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Kay Blyler, RN    570-214-5421    kmblyler@geisinger.edu   
Contact: Paula Janosov, RN    570-808-5892    Pjanosov@geisinger.edu   
Principal Investigator: Sanjay Doddamani, MD         
Lancaster General Health Hospital Recruiting
Lancaster, Pennsylvania, United States, 17603
Contact: Susan Pointer, RN    717-544-5951    spointer2@lghealth.org   
Principal Investigator: Roy Small, MD         
Drexel University Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Janet Matthews       janet.matthews@drexelmed.edu   
Contact: Collen Poisker       cpoisker@drexelmed.edu   
Principal Investigator: Howard Eisen, MD         
VA Pittsburgh Health System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Jennifer Carrick, RN    412-360-3653    Jennifer.Carrick@va.gov   
Contact: Jodi Roberts, RN    412-360-2110    Jodilyn.Roberts@va.gov   
Principal Investigator: Gavin Hickey, MD         
Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 17822
Contact: Paula Janosov, RN    570-808-5892    Pjanosov@geisinger.edu   
Contact: Kay Blyer, RN    5702145421    kmblyer@geisinger.com   
Principal Investigator: Sanjay Doddamani, MD         
Pinnacle Health Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Jennifer Everhart, RN    717-782-5937    jeverhart@pinnaclehealth.org   
Contact: Kathaleen King-Dailey, CRNP    717-231-8445    kkingdailey@pinnaclehealth.org   
United States, Tennessee
Centennial Medical Center - Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sharon Gates, RN    615-524-4459    sharon.gates2@scresearch.net   
Principal Investigator: Thomas McRae, MD         
Sub-Investigator: Thomas Johnston, MD         
United States, Virginia
Virginia Cardiovascular Specialties Suspended
Midlothian, Virginia, United States, 23112
Henrico Doctors' Hospital Recruiting
Richmond, Virginia, United States, 23229
Contact: Christopher Nickolson, MD       nicholson.cs@gmail.com   
Principal Investigator: Christopher Nicholson, MD         
Sub-Investigator: Minh Bui, MD         
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.
  More Information

Additional Information:
Publications:
Responsible Party: Sensible Medical Innovations Ltd.
ClinicalTrials.gov Identifier: NCT02448342     History of Changes
Other Study ID Numbers: CL-00100-P
First Submitted: May 10, 2015
First Posted: May 19, 2015
Last Update Posted: August 2, 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