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| Name | Class |
|---|---|
| Sensible Medical Innovations Ltd. | INDUSTRY |
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This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure
Inpatient management of acute decompensated heart failure centers around the efficient relief of congestion with IV diuretics and vasoactive agents. For the majority of patients, non-invasive, clinical bedside tools such as jugular venous pressure, pulmonary auscultation and daily weights are used to estimate cardiac filling pressures and guide diuresis. However, these methods are subject to significant inter-observer variability and can be unreliable for various reasons. Furthermore, recent studies have shown that overt signs of clinical congestion correlate poorly with hemodynamic congestion assessed by invasive means. Remote Dielectric Sensing is a novel technology that enables the non-invasive assessment of lung fluid content using a wearable vest. ReDS measurements have been shown to correlate with fluid status in hospitalized HF patients and have been used to remotely monitor ambulatory HF patients for signs of pre-clinical hemodynamic congestion. In this prospective, randomized study, we will assess the utility of ReDS guided diuresis in hospitalized patients with acute decompensated heart failure. All patients will receive daily ReDS measurements, but only treating physicians in the intervention group will be able to use these values to guide treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReDS-Guided | Experimental | Patients in the intervention arm will undergo daily measurements of lung fluid content at the bedside with the ReDS vest. The values will be shared with the treating clinicians, who can use the measurements in addition to other standard data to guide diuresis. Patients should be discharged only once their lung fluid content falls within the normal range of 20-35%. |
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| Control | Sham Comparator | Patients in the control arm will also undergo daily measurements of lung fluid content at the beside with the ReDS vest. However, the values will not be shared with the treating clinicians, who will direct management based on standard clinical tools |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReDS-Guided | Device | ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Net Fluid Balance during hospitalization | Cumulative net fluid balance assessed by In's and Out's recorded in the Electronic Medical Record (EMR) during hospitalization | During hospitalization, approximately 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GFR from admission to discharge | Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge | During hospitalization, approximately 7 days |
| Length of Stay in hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Partida-Higuera | Contact | 415-514-1125 | Cynthia.Partida-Higuera@ucsf.edu | |
| Liviu Klein, MD, MS | Contact | 415-476-2143 | liviu.klein@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Liviu Klein, MD, MS | Director, Mechanical Circulatory Support and Heart Failure Device Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19215829 | Background | Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041. | |
| 28341372 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Usual Care | Device | ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria |
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Duration of hospitalization
| During hospitalization, approximately 7 days |
| Major adverse cardiac events at 30 days | The combined rate of cardiovascular mortality or heart failure readmission at 30 days | 30 Days after discharge |
| 23350643 | Background | 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. |