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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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Lung Congestion | Device: ReDS-guided strategy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| 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:
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| Masking: | Double (Participant, Outcomes 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. |
| Primary Purpose: | Treatment |
| Official Title: | Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study |
| Actual Study Start Date : | August 14, 2020 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: ReDS-guided strategy
A discharge scheme based on specific target value given by the device |
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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.
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- 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.
- 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.
- 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.
- Length of stay [ Time Frame: average of 7 days ]Length of stay of index hospitalization
- 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
- 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).
- 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.
- 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.
- 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
- Serum Potassium [ Time Frame: 7 days after discharge ]Serum potassium level to assess dyskalemia
- 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
- Systolic arterial pressure [ Time Frame: 7 days after discharge ]Systolic arterial pressure to assess hypotension
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305717
| Contact: Donna M Mancini | 212-241-7673 ext x47673 | donna.mancini@mountsinai.org | |
| Contact: Danielle Brunjes | 212-241-9886 | danielle.brunjes@mountsinai.org |
| United States, New York | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Danielle Brunjes 212-241-9886 danielle.brunjes@mountsinai.org | |
| Principal Investigator: Donna M Mancini | |
| Principal Investigator: | Donna M Mancini | Icahn School of Medicine |
| Responsible Party: | Donna Mancini, Professor, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT04305717 |
| Other Study ID Numbers: |
GCO 19-2678 |
| First Posted: | March 12, 2020 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Clinical trial Lung congestion Heart failure Diuretics |
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Heart Failure Heart Diseases Cardiovascular Diseases |