ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Dielectric Sensing System, Blinded ReDS data.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial
Overview
This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach. The study seeks to answer the following key questions: 1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge? 2. What is the safety profile of this treatment strategy? Researchers will compare the ReDS-based strategy against the current standard of care. All participants will: * Undergo daily assessments using the ReDS device throughout their hospitalization. * Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.
Interventions
- Device Remote Dielectric Sensing System
The ReDS system consists of 2 sensors that are placed (sitting or supine) on the front (infraclavicular) and back (below the scapula) of the patient's right hemithorax and in 45 seconds accurately quantifies the proportion of fluid in the lung. The sensors are connected via 1 cable to a touchscreen monitor that easily guides the measurement process and stores this information. The accuracy of this technology has been validated with high-resolution chest computed tomography and invasive hemodynam - Device Blinded ReDS data
The responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met.
Primary outcome measures
- Number of participants with an efficacy event at 1 month after discharge [Time frame: From randomization to the end of follow-up at 1 month after hospitalization discharge]
- Number of participant with a safety event at 1 month after discharge [Time frame: From randomization to the end of follow-up at 1 month after hospitalization discharge]
Secondary outcome measures (1)
- Cost-efficacy outcome measure [Time frame: Length of stay of index admission]
Eligibility criteria
Inclusion criteria
- Hospitalized due to heart failure as the main reason, including the presence of symptoms and signs of congestion, regardless of the left ventricular ejection fraction (LVEF).
- NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.
Exclusion criteria
- Height less than 150 cm or greater than 190 cm or body mass index (BMI) less than 22 or greater than 39, conditions where the use of ReDS is not approved.
- Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.
- Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
- Patients with any heart disease requiring a planned surgical intervention (CABG, valve disease, or other) or percutaneous (TAVR, STE-ACS, mitral or tricuspid valve repair, CRT) during the clinical trial.
- Chronic kidney disease with a GFR <20 or on hemodialysis.
- Life expectancy less than 12 months due to non-cardiological origin.
- Participation in another clinical trial with intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 25 centers
- Ramón y Cajal University Hospital — Madrid
- Arnau de Vilanova University Hospital — Barcelona
- Bellvitge University Hospital — Barcelona
- Hospital Clinic — Barcelona
- Hospital del Mar — Barcelona
- Vall d'Hebrón University Hospital — Barcelona
- Reina Sofía University Hospital — Córdoba
- Dr Josep Trueta University Hospital — Girona
- … and 17 more centers
Publications
- Lala A, Barghash MH, Giustino G, Alvarez-Garcia J, Konje S, Parikh A, Ullman J, Keith B, Donehey J, Mitter SS, Trivieri MG, Contreras JP, Burkhoff D, Moss N, Mancini DM, Pinney SP. Early use of remote dielectric sensing after hospitalization to reduce heart failure readmissions. ESC Heart Fail. 2021 Apr;8(2):1047-1054. doi: 10.1002/ehf2.13026. Epub 2020 Dec 18. PMID 33336881
- 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):695-7 PMID 38430084
Identifiers
NCT: NCT07484009 · 208/24 · PI24/01541 · SEC/FEC-INV-CLI 24/17