Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure

NCT ID: NCT03586336

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Heart Failure; With Decompensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ReDS-Guided

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%.

Group Type: EXPERIMENTAL

ReDS-Guided

Intervention Type: 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

Control

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

Group Type: SHAM_COMPARATOR

Usual Care

Intervention Type: DEVICE

ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

Interventions

ReDS-Guided

ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge

Intervention Type: DEVICE

Usual Care

ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensible Medical Innovations Ltd.

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liviu Klein, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Director, Mechanical Circulatory Support and Heart Failure Device Program

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cynthia Partida-Higuera

Role: CONTACT

Cynthia.Partida-Higuera@ucsf.edu

415-514-1125

Liviu Klein, MD, MS

Role: CONTACT

liviu.klein@ucsf.edu

415-476-2143

Facility Contacts

Cassie Nguyen

Role: primary

cassie.nguyen@ucsf.edu

415-353-9124

Liviu Klein, M.D.

Role: backup

liviu.klein@ucsf.edu

415-476-2143

References

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.

Reference Type: BACKGROUND

PMID: 19215829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28341372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23350643 (View on PubMed)

Other Identifiers

RADAR-HF

Identifier Type: -

Identifier Source: org_study_id