Clinical trial NCT03586336: Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Official title: Remote Dielectric Sensing Technology Guided Diuresis in Hospitalized Patients With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure; With Decompensation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Sensible Medical Innovations Ltd.
First posted: 2018-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs
* Patient has signed informed consent and has authorized use and disclosed health information
* Patient is at least 18 years of age
* Patient physically suitable for ReDS measurement
* GFR\>25
* Initial ReDS Measurement \>35%

Exclusion Criteria:

* Patient characteristics excluded from approved use of ReDS system: height less than 155cm or greater than 190cm, BMI \<22 or \>39, chest circumference \<80cm or \>115cm , or flail chest
* Evidence of focal lung lesions on history, physical exam or chest x-ray, including history of pulmonary embolism, active pneumonia, or known lung nodule
* Chronic renal failure (GFR\<25)
* Prior cardiac surgery within 2 months of index admission
* Patient has a ventricular assist device or has had a cardiac transplantation
* Patients in cardiogenic shock at admission requiring inotropic support
* Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy (e.g dextrocardia, lung carcinoma, or pacemaker box in the right chest)

Primary outcomes:
measure: Net Fluid Balance during hospitalization
timeFrame: During hospitalization, approximately 7 days
Secondary outcomes:
measure: Change in GFR from admission to discharge
timeFrame: During hospitalization, approximately 7 days
measure: Length of Stay in hospital
timeFrame: During hospitalization, approximately 7 days
measure: Major adverse cardiac events at 30 days
timeFrame: 30 Days after discharge
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Director, Mechanical Circulatory Support and Heart Failure Device Program
name: Liviu Klein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.