Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients

Heart Failure Clinical Trial

— SMILE™  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02448342
• Other study ID #: CL-00100-P
• Status: Terminated
• Phase: N/A
• First received: May 10, 2015
• Last updated: December 28, 2017
• Start date: September 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2017
• Source: Sensible Medical Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 380
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Suma Health Services	Akron	Ohio
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
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	St Elizabeth Healthcare	Edgewood	Kentucky
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	Cedars Sinai	Hollywood	California
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Encore Research Group	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Scripps Memorial Hospital La Jolla	La Jolla	California
United States	Lancaster General Health Hospital	Lancaster	Pennsylvania
United States	Bryan Heart	Lincoln	Nebraska
United States	North Shore University Hospital	Manhasset	New York
United States	Virginia Cardiovascular Specialties	Midlothian	Virginia
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Edward Heart Hospital	Naperville	Illinois
United States	Centennial Medical Center - Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale University Medical Center	New Haven	Connecticut
United States	Long Island Jewish Hospital	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Weil Cornell Medical Center	New York	New York
United States	Drexel University Medical Center	Philadelphia	Pennsylvania
United States	VA Pittsburgh Health System	Pittsburgh	Pennsylvania
United States	Henrico Doctors' Hospital	Richmond	Virginia
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
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	Prairie Heart Institute / St. John's Hospital	Springfield	Illinois
United States	MedStar Heart and Vascular Institute	Washington	District of Columbia
United States	Washington DC VA Medical Center	Washington	District of Columbia
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sensible Medical Innovations Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of recurrent events of HF readmissions		Entire follow-up period (Expected average of 6.5 months)
Secondary	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)
Secondary	Proportions of total days lost to hospitalization due to HF events		Entire follow-up period (Expected average of 6.5 months)
Secondary	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)

External Links

•   Sponsor web site