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NCT04305717 · ClinicalTrials.gov registry record · NA
Use of ReDS Technology in Patients With Acute Heart Failure
A NA study of Heart Failure and Lung Congestion, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT04305717 is a NA study of Heart Failure and Lung Congestion that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 240 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04305717, a NA study of Heart Failure and Lung Congestion, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE ReDS-guided strategy
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2021-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04305717
The ClinicalTrials.gov registry entry for NCT04305717 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (88% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which ReDS-guided strategy is the first listed.
NCT04305717 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04305717 about?
NCT04305717 is a clinical study titled "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 quan...
What is the current status of trial NCT04305717?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2020-08-14. Estimated completion is 2021-12.
What conditions does trial NCT04305717 study?
This clinical trial studies the following conditions: Heart Failure, Lung Congestion.
What interventions are being tested in trial NCT04305717?
The interventions under investigation include: ReDS-guided strategy (DEVICE).
Who is sponsoring clinical trial NCT04305717?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305717 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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