Use of ReDS Technology in Patients With Acute Heart Failure
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.
Conditions:
🦠 Heart Failure 🦠 Lung Congestion
🗓️ Study Start (Actual) 14 August 2020
🗓️ Primary Completion (Estimated) December 2021
✅ Study Completion (Estimated) December 2021
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 10 March 2020
  • First Submitted that Met QC Criteria 10 March 2020
  • First Posted 12 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 February 2021
  • Last Update Posted 21 February 2021
  • Last Verified February 2021