Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients
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Sensible Medical Innovations (Noninvasive) Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients- a Randomized Controlled Study
1 other identifier
interventional
380
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Sep 2015
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedDecember 29, 2017
August 1, 2017
2.2 years
May 10, 2015
December 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of recurrent events of HF readmissions
Entire follow-up period (Expected average of 6.5 months)
Secondary Outcomes (3)
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)
Study Arms (2)
ReDS Guided Treatment
EXPERIMENTALAfter 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
ACTIVE COMPARATORAfter discharge from hospital, patient will be followed up and medically managed according to standard of care guidelines.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient has had a cardiac transplantation or VAD implantation.
- CRT implantation within 90 days prior to screening or planned implantation during study duration.
- Diagnosis of Severe Pulmonary Hypertension.
- 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).
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of Alabama
Birmingham, Alabama, 35294-0007, United States
Cedars Sinai
Hollywood, California, 90048, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
Scripps Mercy Hospital San Diego
San Diego, California, 92103, United States
UCSF Medical Center, Parnassus
San Francisco, California, 94143, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
Yale University Medical Center
New Haven, Connecticut, 06519, United States
MedStar Heart and Vascular Institute
Washington D.C., District of Columbia, 20010, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Encore Research Group
Jacksonville, Florida, 32207, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Northshore University HealthSystem
Evanston, Illinois, 60201, United States
Advanced Heart Care Group
Fairview Heights, Illinois, 62208, United States
Edward Heart Hospital
Naperville, Illinois, 60540, United States
Prairie Heart Institute / St. John's Hospital
Springfield, Illinois, 62701, United States
St Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
St. Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Hospital
New Hyde Park, New York, 11040, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Weil Cornell Medical Center
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Suma Health Services
Akron, Ohio, 44304, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1252, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Lancaster General Health Hospital
Lancaster, Pennsylvania, 17603, United States
Drexel University Medical Center
Philadelphia, Pennsylvania, 19102, United States
VA Pittsburgh Health System
Pittsburgh, Pennsylvania, 15240, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 17822, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043, United States
Centennial Medical Center - Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Virginia Cardiovascular Specialties
Midlothian, Virginia, 23112, United States
Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
Related Publications (3)
Amir O, Rappaport D, Zafrir B, Abraham WT. A novel approach to monitoring pulmonary congestion in heart failure: initial animal and clinical experiences using remote dielectric sensing technology. Congest Heart Fail. 2013 May-Jun;19(3):149-55. doi: 10.1111/chf.12021. Epub 2013 Jan 25.
PMID: 23350643BACKGROUNDAmir O, Azzam ZS, Gaspar T, Faranesh-Abboud S, Andria N, Burkhoff D, Abbo A, Abraham WT. Validation of remote dielectric sensing (ReDS) technology for quantification of lung fluid status: Comparison to high resolution chest computed tomography in patients with and without acute heart failure. Int J Cardiol. 2016 Oct 15;221:841-6. doi: 10.1016/j.ijcard.2016.06.323. Epub 2016 Jul 1.
PMID: 27434357BACKGROUNDAmir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. 2017 Aug 1;240:279-284. doi: 10.1016/j.ijcard.2017.02.120. Epub 2017 Mar 3.
PMID: 28341372BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Abraham, MD
Ohio State University
- STUDY DIRECTOR
Aharon (Ronnie) Abbo, MD
Sensible Medical Innovations Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2015
First Posted
May 19, 2015
Study Start
September 1, 2015
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
December 29, 2017
Record last verified: 2017-08