Use of ReDS Technology in Patients With Acute Heart Failure
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| ClinicalTrials.gov Identifier: NCT04305717 |
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Recruitment Status :
Recruiting
First Posted : March 12, 2020
Last Update Posted : February 21, 2021
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | March 10, 2020 | ||||||||
| First Posted Date ICMJE | March 12, 2020 | ||||||||
| Last Update Posted Date | February 21, 2021 | ||||||||
| Actual Study Start Date ICMJE | August 14, 2020 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Use of ReDS Technology in Patients With Acute Heart Failure | ||||||||
| Official Title ICMJE | Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The ReDS-SAFE HF trial is a 2-arm randomized clinical trial, in which inpatients with ADHF will be randomized to:
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. |
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| Condition ICMJE |
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| Intervention ICMJE | Device: ReDS-guided strategy
A discharge scheme based on specific target value given by the device
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
240 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2021 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04305717 | ||||||||
| Other Study ID Numbers ICMJE | GCO 19-2678 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Donna Mancini, Icahn School of Medicine at Mount Sinai | ||||||||
| Original Responsible Party | Sean Pinney, Icahn School of Medicine at Mount Sinai, Director of Advanced Heart Failure and Cardiac Transplant Program | ||||||||
| Current Study Sponsor ICMJE | Icahn School of Medicine at Mount Sinai | ||||||||
| Original Study Sponsor ICMJE | Sean Pinney | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Icahn School of Medicine at Mount Sinai | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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