Clinical trial NCT02448342: Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients
Official title: Sensible Medical Innovations (Noninvasive) Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients- a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Remote Patient Monitoring
Non Invasive Lung Fluid Status Monitor
Lead sponsor: Sensible Medical Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 380
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: The rate of recurrent events of HF readmissions
timeFrame: Entire follow-up period (Expected average of 6.5 months)
Secondary outcomes:
measure: Time from discharge until the first event of HF readmissions
timeFrame: Time to event (from discharge until the date of first event of HF readmissions, assessed up to 6.5 months)
measure: Proportions of total days lost to hospitalization due to HF events
timeFrame: Entire follow-up period (Expected average of 6.5 months)
measure: Time from discharge until all-cause mortality
timeFrame: time to event (from time of discharge until the date of first event of HF readmissions, assessed up to 6.5 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Hollywood
country: United States
facility: Cedars Sinai
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: San Diego
country: United States
facility: Scripps Mercy Hospital San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center, Parnassus
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: New Haven
country: United States
facility: Yale University Medical Center
state: Connecticut
city: Washington
country: United States
facility: MedStar Heart and Vascular Institute
state: District of Columbia
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Encore Research Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Elmhurst
country: United States
facility: Elmhurst Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: Northshore University HealthSystem
state: Illinois
city: Fairview Heights
country: United States
facility: Advanced Heart Care Group
state: Illinois
city: Naperville
country: United States
facility: Edward Heart Hospital
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart Institute / St. John's Hospital
state: Illinois
city: Edgewood
country: United States
facility: St Elizabeth Healthcare
state: Kentucky
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Weil Cornell Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Akron
country: United States
facility: Suma Health Services
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health System
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Medical Center - Sarah Cannon Research Institute
state: Tennessee
city: Midlothian
country: United States
facility: Virginia Cardiovascular Specialties
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital
state: Virginia
Study officials:
affiliation: Ohio State University
name: William Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sensible Medical Innovations Ltd.
name: Aharon (Ronnie) Abbo, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.