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Use of ReDS Technology in Patients With Acute Heart Failure

Primary Purpose

Heart Failure, Lung Congestion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReDS-guided strategy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Clinical trial, Lung congestion, Heart failure, Diuretics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ReDS-guided strategy

Standard of care strategy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite outcome
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.

Secondary Outcome Measures

Number of unplanned visits
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.
Number of unplanned hospitalizations
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.
Length of stay
Length of stay of index hospitalization
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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
New York Heart Association functional class
New York Heart Association functional classification from Class 1 (no symptom or limitation to Class IV (severe symptoms or severe limitation).
Orthodema Scale
Signs of systemic congestion by Orthodema scale. Full scale from 0 to 4, with higher score indicating worse health outcomes.
Breathlessness Visual Analog Scale
Signs of resolution of the breathlessness by visual analog scale. Full scale from 0 to 10, with higher score indicating better health outcomes.
Change in NT-proBNP/BNP plasma levels
Time-averaged proportional change in the NT-proBNP/BNP plasma levels at 7 days after discharge as compared from baseline
Serum Potassium
Serum potassium level to assess dyskalemia
Change in Creatinine level
Change in creatinine from at 7 days after discharge as compared to baseline
Systolic arterial pressure
Systolic arterial pressure to assess hypotension

Full Information

First Posted
March 10, 2020
Last Updated
February 18, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04305717
Brief Title
Use of ReDS Technology in Patients With Acute Heart Failure
Official Title
Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Lung Congestion
Keywords
Clinical trial, Lung congestion, Heart failure, Diuretics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The ReDS-SAFE HF trial is a 2-arm randomized clinical trial, in which inpatients with ADHF will be randomized to: Standard of care strategy, with a discharge scheme based on current clinical practice, or ReDS-guided strategy, with a discharge scheme based on specific target value given by the device.
Masking
ParticipantOutcomes Assessor
Masking Description
Participant masking: Patients will be blinded to the treatment groups. ReDS tests will be performed for all study patients, but due to the inherent characteristics of this design, only the treating physicians will be blinded in the "standard of care" arm. Outcome assessor masking: Two independent cardiologist will assess the outcomes blinded to the intervention arm.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ReDS-guided strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care strategy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ReDS-guided strategy
Intervention Description
A discharge scheme based on specific target value given by the device
Primary Outcome Measure Information:
Title
Composite outcome
Description
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.
Time Frame
30 days after discharge
Secondary Outcome Measure Information:
Title
Number of unplanned visits
Description
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.
Time Frame
30 days after discharge
Title
Number of unplanned hospitalizations
Description
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.
Time Frame
30 days after discharge
Title
Length of stay
Description
Length of stay of index hospitalization
Time Frame
average of 7 days
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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
Time Frame
7 days after discharge
Title
New York Heart Association functional class
Description
New York Heart Association functional classification from Class 1 (no symptom or limitation to Class IV (severe symptoms or severe limitation).
Time Frame
7 days after discharge
Title
Orthodema Scale
Description
Signs of systemic congestion by Orthodema scale. Full scale from 0 to 4, with higher score indicating worse health outcomes.
Time Frame
7 days after discharge
Title
Breathlessness Visual Analog Scale
Description
Signs of resolution of the breathlessness by visual analog scale. Full scale from 0 to 10, with higher score indicating better health outcomes.
Time Frame
7 days after discharge
Title
Change in NT-proBNP/BNP plasma levels
Description
Time-averaged proportional change in the NT-proBNP/BNP plasma levels at 7 days after discharge as compared from baseline
Time Frame
baseline and 7 days after discharge
Title
Serum Potassium
Description
Serum potassium level to assess dyskalemia
Time Frame
7 days after discharge
Title
Change in Creatinine level
Description
Change in creatinine from at 7 days after discharge as compared to baseline
Time Frame
baseline and 7 days after discharge
Title
Systolic arterial pressure
Description
Systolic arterial pressure to assess hypotension
Time Frame
7 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna M Mancini
Phone
212-241-7673
Ext
x47673
Email
donna.mancini@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Brunjes
Phone
212-241-9886
Email
danielle.brunjes@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna M Mancini
Organizational Affiliation
Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Brunjes
Phone
212-241-9886
Email
danielle.brunjes@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Donna M Mancini

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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30700139
Citation
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Results Reference
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Use of ReDS Technology in Patients With Acute Heart Failure

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