Use of ReDS Technology in Patients With Acute Heart Failure
NCT ID: NCT04305717
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2020-08-14
2021-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Standard of care strategy, with a discharge scheme based on current clinical practice, or
2. ReDS-guided strategy, with a discharge scheme based on specific target value given by the device.
TREATMENT
DOUBLE
Outcome assessor masking: Two independent cardiologist will assess the outcomes blinded to the intervention arm.
Study Groups
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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.
ReDS-guided strategy
A discharge scheme based on specific target value given by the device
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.
No interventions assigned to this group
Interventions
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ReDS-guided strategy
A discharge scheme based on specific target value given by the device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Donna Mancini
Professor
Principal Investigators
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Donna M Mancini
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
Kociol RD, McNulty SE, Hernandez AF, Lee KL, Redfield MM, Tracy RP, Braunwald E, O'Connor CM, Felker GM; NHLBI Heart Failure Network Steering Committee and Investigators. Markers of decongestion, dyspnea relief, and clinical outcomes among patients hospitalized with acute heart failure. Circ Heart Fail. 2013 Mar;6(2):240-5. doi: 10.1161/CIRCHEARTFAILURE.112.969246. Epub 2012 Dec 18.
Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, Dickstein K, Drazner MH, Fonarow GC, Jaarsma T, Jondeau G, Sendon JL, Mebazaa A, Metra M, Nieminen M, Pang PS, Seferovic P, Stevenson LW, van Veldhuisen DJ, Zannad F, Anker SD, Rhodes A, McMurray JJ, Filippatos G; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the acute heart failure committee of the heart failure association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010 May;12(5):423-33. doi: 10.1093/eurjhf/hfq045. Epub 2010 Mar 30.
Amir O, Rappaport D, Zafrir B, Abraham WT. A novel approach to monitoring pulmonary congestion in heart failure: initial animal and clinical experiences using remote dielectric sensing technology. Congest Heart Fail. 2013 May-Jun;19(3):149-55. doi: 10.1111/chf.12021. Epub 2013 Jan 25.
Gargani L, Pang PS, Frassi F, Miglioranza MH, Dini FL, Landi P, Picano E. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: a lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4.
Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.
Amir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. 2017 Aug 1;240:279-284. doi: 10.1016/j.ijcard.2017.02.120. Epub 2017 Mar 3.
Goldgrab D, Balakumaran K, Kim MJ, Tabtabai SR. Updates in heart failure 30-day readmission prevention. Heart Fail Rev. 2019 Mar;24(2):177-187. doi: 10.1007/s10741-018-9754-4.
Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3.
Picano E, Gargani L, Gheorghiade M. Why, when, and how to assess pulmonary congestion in heart failure: pathophysiological, clinical, and methodological implications. Heart Fail Rev. 2010 Jan;15(1):63-72. doi: 10.1007/s10741-009-9148-8.
Barghash MH, Lala A, Giustino G, Parikh A, Ullman J, Mitter SS, et al. Use of Remote Dielectric Sensing (ReDS) as Point-of-Care Testing Following Heart Failure Hospitalization and Risk of 30-Day Readmission. J Hear Lung Transplant. 2019;38(4):S140-1
Alvarez-Garcia J, Lala A, Rivas-Lasarte M, De Rueda C, Brunjes D, Lozano-Jimenez S, Garcia-Sebastian C, Mitter S, Remior P, Jimenez-Blanco Bravo M, Del Prado S, Barghash M, Gonzalez-Ferrer E, Ullman J, Cobo M, Segovia-Cubero J, Zamorano JL, Pinney SP, Mancini D. Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial. JACC Heart Fail. 2024 Apr;12(4):695-706. doi: 10.1016/j.jchf.2024.01.002. Epub 2024 Feb 28.
Other Identifiers
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GCO 19-2678
Identifier Type: -
Identifier Source: org_study_id
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