Use of ReDS Technology in Patients With Acute Heart Failure

February 18, 2021 updated by: Donna Mancini, Icahn School of Medicine at Mount Sinai

Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study

Background: Fluid overload, especially pulmonary congestion, is one of the main contributors into heart failure (HF) readmission risk and it is a clinical challenge for clinicians. The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively. Previous non-randomized studies suggest that ReDS-guided management has the potential to reduce readmissions in HF patients recently discharged from the hospital.

Aims: To test whether a ReDS-guided strategy during HF admission is superior to the standard of care during a 1-month follow up.

Methods: The ReDS-SAFE HF trial is an investigator-initiated, single center, single blind, 2-arm randomized clinical trial, in which ~240 inpatients with acutely decompensated HF at Mount Sinai Hospital will be randomized to a) standard of care strategy, with a discharge scheme based on current clinical practice, or b) ReDS-guided strategy, with a discharge scheme based on specific target value given by the device on top of the current clinical practice. ReDS tests will be performed for all study patients, but results will be blinded for treating physicians in the "standard of care" arm. The primary outcome will be a composite of unplanned visit for HF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge. Secondary outcomes including the components of the primary outcome alone, length of stay, quality of life, time-averaged proportional change in the natriuretic peptides plasma levels, and safety events as symptomatic hypotension, diselectrolytemias or worsening of renal function.

Conclusions: The ReDS-SAFE HF trial will help to clarify the efficacy of a ReDS-guided strategy during HF-admission to improve the short-term prognosis of patients after a HF admission.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is an increasing epidemic and a major public health priority, affecting more than 6 million patients in the United States of America (1). Specially, acutely decompensated HF (ADHF) is the most common cause of hospitalization in adults older than 65 years, and is associated with high rates of morbidity and mortality. Despite advances in pharmacological treatment and early follow-up programs in HF patients, readmission rates remain unacceptably high (2).

Fluid overload is a key feature in the pathophysiology of ADHF and residual congestion at the time of hospital discharge is one of the main contributors into readmission risk (3-5). Typically, fluid overload has been assessed through symptoms and signs, as well as other tools such as chest X-ray, plasma biomarkers, and echocardiography (6). 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. In recent years, invasive hemodynamic measurements to inform medical management of congestion facilitated by implantable pulmonary artery pressure sensors have been shown to reduce HF readmissions (7). Unfortunately, due to its invasive nature as well as reimbursement and insurance coverage issues, its widespread adoption has been limited.

Thus, the use of a non-invasive assessment of volume status to guide HF management and identify a state of "euvolemia" is an attractive tool, particularly during admission and early phase after discharge, which is a vulnerable period for recurrent congestion (8). The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively (9). Though limited experience from non-randomized studies suggest that ReDS-guided management has the potential to reduce readmissions in ADHF patients recently discharged from the hospital (10, 11), nevertheless data to substantiate the employment of such as strategy is lacking. The study team hypothesizes that a ReDS-guided strategy to measure the percent of lung water volume as a surrogate of congestion during HF hospitalization will help to determine the appropriate timing of discharge and will accordingly be associated with a better short-term prognosis.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Donna M Mancini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Currently hospitalized for a primary diagnosis of HF, including symptoms and signs of fluid overload, regardless of left ventricular ejection fraction (LVEF), and a NT-proBNP concentration of ≥ 400 pg/L or a BNP concentration of ≥ 100 pg/L

Exclusion Criteria:

  • Patient characteristics excluded from approved use of ReDS system: height <155cm or >190cm, BMI <22 or >39
  • Patients discharged on inotropes, or with a left ventricular assist device or cardiac transplantation
  • Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy
  • End stage renal disease on hemodialysis
  • Life expectancy <12 months due to non-cardiac comorbidities
  • Participating in another randomized study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReDS-guided strategy
For patients in this arm, daily measurements from the device will be revealed to the treating physician. Discharge can be planned when the clinical stability is achieved and the ReDS value is ≤35%. In case of a ReDS value >35%, treating physicians will follow a predefined algorithm before discharge to improve the results of ReDS test.
Device: ReDS-guided strategy
A discharge scheme based on specific target value given by the device
No Intervention: Standard of care strategy
The drugs dosage, especially diuretics, will be selected according to the presence of symptoms and signs of systemic congestion and according to current recommendations. All the daily ReDS measurements will be blinded to the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome
Time Frame: 30 days after discharge
A composite of unplanned visit for ADHF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge.
30 days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unplanned visits
Time Frame: 30 days after discharge
Unplanned visits for worsening HF will be defined as visits to the emergency department or unscheduled visits to the HF unit as a result of signs and/or symptoms of worsening HF that required iv diuretic treatment or diuretic increase with a hospital stay of <24 h.
30 days after discharge
Number of unplanned hospitalizations
Time Frame: 30 days after discharge
Hospitalization for worsening HF will be defined as a stay in hospital for >24 h mainly as a result of signs and/or symptoms of worsening HF.
30 days after discharge
Length of stay
Time Frame: average of 7 days
Length of stay of index hospitalization
average of 7 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 7 days after discharge
QoL evaluated by the KCCQ test which is a 23-item, self-administered instrument. Full scale range from 0-100, with higher scores reflecting better health status
7 days after discharge
New York Heart Association functional class
Time Frame: 7 days after discharge
New York Heart Association functional classification from Class 1 (no symptom or limitation to Class IV (severe symptoms or severe limitation).
7 days after discharge
Orthodema Scale
Time Frame: 7 days after discharge
Signs of systemic congestion by Orthodema scale. Full scale from 0 to 4, with higher score indicating worse health outcomes.
7 days after discharge
Breathlessness Visual Analog Scale
Time Frame: 7 days after discharge
Signs of resolution of the breathlessness by visual analog scale. Full scale from 0 to 10, with higher score indicating better health outcomes.
7 days after discharge
Change in NT-proBNP/BNP plasma levels
Time Frame: baseline and 7 days after discharge
Time-averaged proportional change in the NT-proBNP/BNP plasma levels at 7 days after discharge as compared from baseline
baseline and 7 days after discharge
Serum Potassium
Time Frame: 7 days after discharge
Serum potassium level to assess dyskalemia
7 days after discharge
Change in Creatinine level
Time Frame: baseline and 7 days after discharge
Change in creatinine from at 7 days after discharge as compared to baseline
baseline and 7 days after discharge
Systolic arterial pressure
Time Frame: 7 days after discharge
Systolic arterial pressure to assess hypotension
7 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Donna M Mancini, Icahn School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 19-2678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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