Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients
NCT ID: NCT02448342
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
380 participants
INTERVENTIONAL
2015-09-30
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Standard of Care- Control arm
After discharge from hospital, patient will be followed up and medically managed according to standard of care guidelines.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. CRT implantation within 90 days prior to screening or planned implantation during study duration.
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).
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
21 Years
ALL
No
Sponsors
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Sensible Medical Innovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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William Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Aharon (Ronnie) Abbo, MD
Role: STUDY_DIRECTOR
Sensible Medical Innovations Ltd.
Locations
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University of Alabama
Birmingham, Alabama, United States
Cedars Sinai
Hollywood, California, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Scripps Mercy Hospital San Diego
San Diego, California, United States
UCSF Medical Center, Parnassus
San Francisco, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Yale University Medical Center
New Haven, Connecticut, United States
MedStar Heart and Vascular Institute
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Encore Research Group
Jacksonville, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Northshore University HealthSystem
Evanston, Illinois, United States
Advanced Heart Care Group
Fairview Heights, Illinois, United States
Edward Heart Hospital
Naperville, Illinois, United States
Prairie Heart Institute / St. John's Hospital
Springfield, Illinois, United States
St Elizabeth Healthcare
Edgewood, Kentucky, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Hospital
New Hyde Park, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Weil Cornell Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Suma Health Services
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Lancaster General Health Hospital
Lancaster, Pennsylvania, United States
Drexel University Medical Center
Philadelphia, Pennsylvania, United States
VA Pittsburgh Health System
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Centennial Medical Center - Sarah Cannon Research Institute
Nashville, Tennessee, United States
Virginia Cardiovascular Specialties
Midlothian, Virginia, United States
Henrico Doctors' Hospital
Richmond, Virginia, United States
Countries
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References
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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.
Amir 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.
Amir 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.
Related Links
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Sponsor web site
Other Identifiers
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CL-00100-P
Identifier Type: -
Identifier Source: org_study_id