[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630156":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":341,"collaborators":345,"id":398,"slug":399,"hasResults":400,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":400,"sex":406,"minAge":407,"maxAge":26,"enrollmentInfo":408,"targetDuration":26,"studyType":411,"phases":412,"briefSummary":414,"conditions":415,"keywords":419,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ReDS-guided strategy","EXPERIMENTAL","Each day, the clinician responsible for the patient will have access to the ReDS value and will adjust the treatment according to the study's diuretic protocol. The responsible physician can discharge the patient if the clinical stability criteria are met, and the ReDS value is below 35% and a relative reduction of 10% or more from the admission ReDS value has been achieved (i.e. a patient admitted with a ReDS value of 36% should be discharged with a ReDS of 32% at least; or a patient admitted with a ReDS of 34% should be discharged with a ReDS of 31% at least). If the ReDS criteria are not met, the patient should remain hospitalized for another day until these conditions are met. Clinical stability is defined as the presence of at least 2 of the following 3 conditions: i) discharge weight lower than admission weight, ii) at least a 30% reduction in natriuretic peptide from admission, and iii) a score \\\u003C2 in the Orthoedema score",[13],"Device: Remote Dielectric Sensing System",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual clinical practice strategy","SHAM_COMPARATOR","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.",[19],"Device: Blinded ReDS data",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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 hemodynamic measurements with a Swan-Ganz catheter. Normal ReDS values range between 20% and 35% (i.e., 20-35% of the lung would be fluid). Above 35% is considered congestive, whereas below 20% the lung would be \"dry\" or dehydrated.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Blinded ReDS data",[15],[31],{"name":32,"affiliation":33,"role":34},"Jesús Álvarez-García, MD, PhD","Ramón y Cajal University Hospital, Madrid, Spain","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","34 667495661","jalvarezg82@gmail.com",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Cristina Rey Iborra, BSN","creyi@salud.madrid.org",[44,61,75,85,95,105,115,128,141,151,161,171,181,191,201,211,224,237,250,263,276,289,302,315,328],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ramón y Cajal University Hospital","RECRUITING","Madrid","28034","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-3.70256,40.4165,{"lat":55,"lon":54},[58,60],{"name":32,"role":37,"phone":59,"phoneExt":26,"email":39},"34 677495661",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},{"facility":62,"status":63,"city":64,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Arnau de Vilanova University Hospital","NOT_YET_RECRUITING","Barcelona",{"type":52,"coordinates":66},[67,68],2.15899,41.38879,{"lat":68,"lon":67},[71],{"name":72,"role":37,"phone":73,"phoneExt":26,"email":74},"Ramón Bascompte Claret, MD, PhD","34 961 97 60 00","rbascompte.lleida.ics@gencat.cat",{"facility":76,"status":46,"city":64,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Bellvitge University Hospital",{"type":52,"coordinates":78},[67,68],{"lat":68,"lon":67},[81],{"name":82,"role":37,"phone":83,"phoneExt":26,"email":84},"Herminio Morillas Climent, MD, PhD","34 932 60 75 00","herminiomorillas@bellvitgehospital.cat",{"facility":86,"status":63,"city":64,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Hospital Clinic",{"type":52,"coordinates":88},[67,68],{"lat":68,"lon":67},[91],{"name":92,"role":37,"phone":93,"phoneExt":26,"email":94},"Eduard Solé González, MD, PhD","34 932 27 54 00","edsole@clinic.cat",{"facility":96,"status":46,"city":64,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Hospital del Mar",{"type":52,"coordinates":98},[67,68],{"lat":68,"lon":67},[101],{"name":102,"role":37,"phone":103,"phoneExt":26,"email":104},"Sandra Valdivielso Moré, MD, PhD","34 932 48 30 00","svaldivielso@hmar.cat",{"facility":106,"status":63,"city":64,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Vall d'Hebrón University Hospital",{"type":52,"coordinates":108},[67,68],{"lat":68,"lon":67},[111],{"name":112,"role":37,"phone":113,"phoneExt":26,"email":114},"Toni Soriano Colomé, MD, PhD","34 934 89 30 00","tonisorianocolome@gmail.com",{"facility":116,"status":46,"city":117,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Reina Sofía University Hospital","Córdoba",{"type":52,"coordinates":119},[120,121],-4.77275,37.89155,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":126,"phoneExt":26,"email":127},"Manuel Pérez Anguita, MD, PhD","34 911 91 40 00","manuelp.anguita.sspa@juntadeandalucia.es",{"facility":129,"status":46,"city":130,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Dr Josep Trueta University Hospital","Girona",{"type":52,"coordinates":132},[133,134],2.82493,41.98311,{"lat":134,"lon":133},[137],{"name":138,"role":37,"phone":139,"phoneExt":26,"email":140},"Aleix Tort Pal, MD, PhD","34 972 94 02 00","afort.girona.ics@gencat.cat",{"facility":142,"status":46,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"12 de Octubre University Hospital",{"type":52,"coordinates":144},[54,55],{"lat":55,"lon":54},[147],{"name":148,"role":37,"phone":149,"phoneExt":26,"email":150},"Laura Morán Fernandez, MD","34 913 90 80 00","lauramoranfernandez@gmail.com",{"facility":152,"status":63,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"Clínico San Carlos University Hospital",{"type":52,"coordinates":154},[54,55],{"lat":55,"lon":54},[157],{"name":158,"role":37,"phone":159,"phoneExt":26,"email":160},"Josebe Goirigolzarri Artaza, MD, PhD","34 913 30 30 00","josebegoiri@gmail.com",{"facility":162,"status":63,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"Fundación Jiménez Díaz University Hospital",{"type":52,"coordinates":164},[54,55],{"lat":55,"lon":54},[167],{"name":168,"role":37,"phone":169,"phoneExt":26,"email":170},"Mikel Taibo Urquía, MD, PhD","34 915 50 48 00","Mikel.taibo@fjd.es",{"facility":172,"status":63,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"Gregorio Marañón University Hospital",{"type":52,"coordinates":174},[54,55],{"lat":55,"lon":54},[177],{"name":178,"role":37,"phone":179,"phoneExt":26,"email":180},"Zorba Blázquez Bermejo, MD, PhD","34 915 86 80 00","zorbablbe@gmail.com",{"facility":182,"status":46,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"La Paz University Hospital",{"type":52,"coordinates":184},[54,55],{"lat":55,"lon":54},[187],{"name":188,"role":37,"phone":189,"phoneExt":26,"email":190},"Angel Iniesta Manjavacas, MD, PhD","34 917 27 70 00","a.m.iniesta84@gmail.com",{"facility":192,"status":63,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"La Princesa University Hospital",{"type":52,"coordinates":194},[54,55],{"lat":55,"lon":54},[197],{"name":198,"role":37,"phone":199,"phoneExt":26,"email":200},"Pablo Díez Villanueva, MD, PhD","34 915 20 22 00","pdiezvillanueva@secardiologia.es",{"facility":202,"status":46,"city":47,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":203,"geoPoint":205,"contacts":206},"Puerta de Hierro Majadahonda University Hospital",{"type":52,"coordinates":204},[54,55],{"lat":55,"lon":54},[207],{"name":208,"role":37,"phone":209,"phoneExt":26,"email":210},"Mercedes Rivas-Lasarte, MD, PhD","34 911 91 60 00","rivaslasarte@gmail.com",{"facility":212,"status":46,"city":213,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Virgen de la Victoria University Hospital","Málaga",{"type":52,"coordinates":215},[216,217],-4.42034,36.72016,{"lat":217,"lon":216},[220],{"name":221,"role":37,"phone":222,"phoneExt":26,"email":223},"Ainhoa Robles Mezcua, MD, PhD","34 951 03 20 00","ainhoa.mezcua@gmail.com",{"facility":225,"status":63,"city":226,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Virgen de la Arrixaca","Murcia",{"type":52,"coordinates":228},[229,230],-1.13004,37.98704,{"lat":230,"lon":229},[233],{"name":234,"role":37,"phone":235,"phoneExt":26,"email":236},"Noelia Fernández Villa, MD","34 968 36 95 00","noelia.fernandez7@um.es",{"facility":238,"status":63,"city":239,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Complejo Asistencial Universitario de Salamanca","Salamanca",{"type":52,"coordinates":241},[242,243],-3.67975,40.42972,{"lat":243,"lon":242},[246],{"name":247,"role":37,"phone":248,"phoneExt":26,"email":249},"David González Calle, MD, PhD","34 923 29 11 00","davidgonzalezcalle@gmail.com",{"facility":251,"status":46,"city":252,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"San Juan Despí Moisès Broggi Hospital","Sant Joan Despí",{"type":52,"coordinates":254},[255,256],2.0574,41.36718,{"lat":256,"lon":255},[259],{"name":260,"role":37,"phone":26,"phoneExt":261,"email":262},"Román Freixa Pamies, MD, PhD","34 935531200","roman.freixa@sanitatintegral.org",{"facility":264,"status":63,"city":265,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Marqués de Valdecilla University Hospital","Santander",{"type":52,"coordinates":267},[268,269],-3.80493,43.46589,{"lat":269,"lon":268},[272],{"name":273,"role":37,"phone":274,"phoneExt":26,"email":275},"Gonzalo Martín Gorrria, MD","34 942 20 25 20","gonzalo.martin@scsalud.es",{"facility":277,"status":46,"city":278,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Complejo Hospitalario Universitario de Santiago","Santiago de Compostela",{"type":52,"coordinates":280},[281,282],-8.54569,42.88052,{"lat":282,"lon":281},[285],{"name":286,"role":37,"phone":287,"phoneExt":26,"email":288},"Inés Gómez Otero, MD, PhD","34 981 95 00 00","mgo300971@gmail.com",{"facility":290,"status":63,"city":291,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Virgen de la Macarena University Hospital","Seville",{"type":52,"coordinates":293},[294,295],-5.97317,37.38283,{"lat":295,"lon":294},[298],{"name":299,"role":37,"phone":300,"phoneExt":26,"email":301},"Alejandro Recio Mayoral, MD, PhD","34 955 00 80 00","recioalejandro@yahoo.es",{"facility":303,"status":63,"city":304,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Sant Joan XXIII University Hospital","Tarragona",{"type":52,"coordinates":306},[307,308],1.24544,41.11905,{"lat":308,"lon":307},[311],{"name":312,"role":37,"phone":313,"phoneExt":26,"email":314},"María Ferrero Guillem, MD","34 977 29 58 00","mariaferrero23@gmail.com",{"facility":316,"status":63,"city":317,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Hospital General Universitario de Toledo","Toledo",{"type":52,"coordinates":319},[320,321],-4.02263,39.8581,{"lat":321,"lon":320},[324],{"name":325,"role":37,"phone":326,"phoneExt":26,"email":327},"Marta Flores Hernáne¡, MD","34 925 26 92 00","flores13marta@gmail.com",{"facility":329,"status":63,"city":330,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Clínico University Hospital","Valencia",{"type":52,"coordinates":332},[333,334],-0.37966,39.47391,{"lat":334,"lon":333},[337],{"name":338,"role":37,"phone":339,"phoneExt":26,"email":340},"Julio Núñez Villota, MD, PhD","34 961 97 35 00","yulnunez@gmail.com",{"type":34,"investigatorFullName":342,"investigatorTitle":343,"investigatorAffiliation":344,"oldNameTitle":26,"oldOrganization":26},"Jesus Alvarez-Garcia","Head of the Heart Failure Section","Hospital Universitario Ramon y Cajal",[346,347,349,351,353,355,357,359,361,363,364,367,369,371,372,374,376,378,381,383,385,387,389,391,393,396],{"name":344,"class":6},{"name":348,"class":6},"Hospital Universitario 12 de Octubre",{"name":350,"class":6},"Hospital San Carlos, Madrid",{"name":352,"class":6},"Hospital Universitario Fundación Jiménez Díaz",{"name":354,"class":6},"Hospital Universitario La Paz",{"name":356,"class":6},"Hospital General Universitario Gregorio Marañon",{"name":358,"class":6},"Hospital Clinic of Barcelona",{"name":360,"class":6},"Hospital Vall d'Hebron",{"name":362,"class":6},"Hospital Universitari de Bellvitge",{"name":96,"class":6},{"name":365,"class":366},"Hospital Sant Joan Despí Moisès Broggi","UNKNOWN",{"name":368,"class":6},"Hospital Arnau de Vilanova",{"name":370,"class":6},"Hospital Universitario Virgen de la Arrixaca",{"name":277,"class":6},{"name":373,"class":6},"Salamanca University Hospital",{"name":375,"class":6},"Complejo Hospitalario Toledo",{"name":377,"class":6},"Hospital Universitario Virgen Macarena",{"name":379,"class":380},"Hospital Universitario Reina Sofia de Cordoba","OTHER_GOV",{"name":382,"class":6},"Hospital Universitario Virgen de la Victoria",{"name":384,"class":6},"Hospital Universitario Marqués de Valdecilla",{"name":386,"class":6},"Hospital Clínico Universitario de Valencia",{"name":388,"class":6},"Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III",{"name":390,"class":6},"Puerta de Hierro University Hospital",{"name":392,"class":366},"La Princesa University Hospital Madrid",{"name":394,"class":395},"University Hospital of Girona Dr. Josep Trueta","NETWORK",{"name":397,"class":6},"Joan XXIII University Hospital","100630156","reds-guided-decongestion-strategy-in-patients-hospitalized-for-heart-failure-100630156",false,"NCT07484009","ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure","ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial","ReDS-SAFE HF 2","Inclusion Criteria:\n\n1. 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).\n2. NT-proBNP greater than 1000 pg\u002FL or BNP greater than 300 pg\u002FL upon admission.\n\nExclusion Criteria:\n\n1. 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.\n2. Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.\n3. Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).\n4. 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.\n5. Chronic kidney disease with a GFR \\\u003C20 or on hemodialysis.\n6. Life expectancy less than 12 months due to non-cardiological origin.\n7. Participation in another clinical trial with intervention.","ALL","18 Years",{"count":409,"type":410},1014,"ESTIMATED","INTERVENTIONAL",[413],"NA","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.\n\nThe study seeks to answer the following key questions:\n\n1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge?\n2. What is the safety profile of this treatment strategy?\n\nResearchers will compare the ReDS-based strategy against the current standard of care. All participants will:\n\n* Undergo daily assessments using the ReDS device throughout their hospitalization.\n* Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.",[416,417,418],"Acute Heart Failure (AHF)","Heart Failure (for Example, Fluid Overload)","Heart Failure Hospitalization",[420,421,422,423,424],"Heart failure","Congestion","ReDS","Fluid Overload","Randomized Clinical Trial","2026-03-16",{"date":427,"type":428},"2026-03-19","ACTUAL",{"date":430,"type":428},"2026-01-29",{"date":432,"type":410},"2027-08-31",{"name":5,"class":6},25]