ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Официальное название

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Number of participants with an efficacy event at 1 month after discharge [Срок оценки: 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 [Срок оценки: From randomization to the end of follow-up at 1 month after hospitalization discharge]

Вторичные конечные точки (1)

• Cost-efficacy outcome measure [Срок оценки: Length of stay of index admission]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 25 центров

• 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
• … и ещё 17 центров

Публикации

• 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

Идентификаторы

NCT: NCT07484009 · 208/24 · PI24/01541 · SEC/FEC-INV-CLI 24/17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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