[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543785":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":222,"collaborators":18,"id":224,"slug":225,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":226,"sex":232,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":18,"studyType":238,"phases":239,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},{"fullName":5,"class":6},"AquaPass Medical Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AquaPass","EXPERIMENTAL","An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff",[13],"Device: AquaPass System",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","AquaPass System","a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis",[9],[26],{"name":27,"affiliation":28,"role":29},"Scott C Feitell, DO","Rochester Regional Health","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","(585) 442 5320","scott.feitell@rochesterregional.org",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Julie Mooney, RN","585-738-3409","julie.mooney@rochesterregional.org",[40,63,78,98,122,137,155,169,193,209],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"UC San Diego Health-Sulpizio Cardiovascular Center","RECRUITING","La Jolla","California","92037","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-117.2742,32.84727,{"lat":52,"lon":51},[55,59,60],{"name":56,"role":32,"phone":57,"phoneExt":18,"email":58},"Ori Ben-Yehuda, MD","858-246-2413","obenyehuda@health.ucsd.edu",{"name":56,"role":29,"phone":18,"phoneExt":18,"email":18},{"name":61,"role":62,"phone":18,"phoneExt":18,"email":18},"Nicholas Wettersten, MD","SUB_INVESTIGATOR",{"facility":64,"status":42,"city":65,"state":44,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"UC San Francisco","San Francisco","94143",{"type":49,"coordinates":68},[69,70],-122.41942,37.77493,{"lat":70,"lon":69},[73,77],{"name":74,"role":32,"phone":75,"phoneExt":18,"email":76},"Liviu Klein, MD","619-972-4251","liviu.klein@ucsf.edu",{"name":74,"role":29,"phone":18,"phoneExt":18,"email":18},{"facility":79,"status":42,"city":80,"state":81,"zip":82,"country":46,"countryCode":47,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"University of Minnesota","Minneapolis","Minnesota","55455",{"type":49,"coordinates":84},[85,86],-93.26384,44.97997,{"lat":86,"lon":85},[89,93,97],{"name":90,"role":32,"phone":91,"phoneExt":18,"email":92},"Tamas Alexy, MD","612-626-1240","alexy001@umn.edu",{"name":94,"role":32,"phone":95,"phoneExt":18,"email":96},"Gretchen Peichel, RN-CRC","612-626-6237","gpeichel@umn.edu",{"name":90,"role":29,"phone":18,"phoneExt":18,"email":18},{"facility":99,"status":42,"city":100,"state":100,"zip":101,"country":46,"countryCode":47,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Northwell Health- Lenox Hill Hospital","New York","10075",{"type":49,"coordinates":103},[104,105],-74.00597,40.71427,{"lat":105,"lon":104},[108,112,116,118,120],{"name":109,"role":32,"phone":110,"phoneExt":18,"email":111},"Gerin Stevens, MD","516-562-1428","gstevens1@northwell.edu",{"name":113,"role":32,"phone":114,"phoneExt":18,"email":115},"Virgenmina Lugaro","212-434-6626","vlugaro@northwell.edu",{"name":117,"role":62,"phone":18,"phoneExt":18,"email":18},"Sirish Vullaganti,, MD",{"name":119,"role":29,"phone":18,"phoneExt":18,"email":18},"Gerin Stevens,, MD",{"name":121,"role":62,"phone":18,"phoneExt":18,"email":18},"Miguel Alvarez,, MD",{"facility":28,"status":42,"city":123,"state":100,"zip":124,"country":46,"countryCode":47,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Rochester","14621",{"type":49,"coordinates":126},[127,128],-77.61556,43.15478,{"lat":128,"lon":127},[131,133],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":132},"Scott.Feitell@rochesterregional.org",{"name":134,"role":32,"phone":18,"phoneExt":135,"email":136},"Kara Cristales, RN","585-922-3536","kara.cristales@rochesterregional.org",{"facility":138,"status":42,"city":139,"state":140,"zip":141,"country":46,"countryCode":47,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Mission Hospital","Asheville","North Carolina","28801",{"type":49,"coordinates":143},[144,145],-82.55402,35.60095,{"lat":145,"lon":144},[148,152,153],{"name":149,"role":32,"phone":150,"phoneExt":18,"email":151},"Vinay Thohan, 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Hospital","Austin","Texas","78705",{"type":49,"coordinates":175},[176,177],-97.74306,30.26715,{"lat":177,"lon":176},[180,184,185,187,189,191],{"name":181,"role":32,"phone":182,"phoneExt":18,"email":183},"Kunjan Bhatt, MD","512-206-3600","kbhatt@austinheart.com",{"name":181,"role":29,"phone":18,"phoneExt":18,"email":18},{"name":186,"role":62,"phone":18,"phoneExt":18,"email":18},"Jerome Thomas, MD",{"name":188,"role":62,"phone":18,"phoneExt":18,"email":18},"Laura Calais, APRN",{"name":190,"role":62,"phone":18,"phoneExt":18,"email":18},"Jennifer Lord, MSN",{"name":192,"role":62,"phone":18,"phoneExt":18,"email":18},"Brooke Eden, APRN",{"facility":194,"status":42,"city":195,"state":18,"zip":196,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Rambam Medical Campus","Haifa","3109601","Israel","IL",{"type":49,"coordinates":200},[201,202],34.99928,32.81303,{"lat":202,"lon":201},[205],{"name":206,"role":32,"phone":207,"phoneExt":18,"email":208},"Doron Aronson, MD, PhD","972-4-777-2342","d_aronson@rambam.health.gov.il",{"facility":210,"status":42,"city":211,"state":18,"zip":212,"country":197,"countryCode":198,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Rabin Medical Center","Petah Tikva","49100",{"type":49,"coordinates":214},[215,216],34.88747,32.08707,{"lat":216,"lon":215},[219],{"name":220,"role":32,"phone":18,"phoneExt":18,"email":221},"Tuvia Ben Gal, MD","bengaltu@gmail.com",{"type":223,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100543785","reducing-fluid-overload-in-heart-failure-patients-using-a-non-invasive-renal-independent-system-100543785",false,"NCT06360380","Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System","REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients","REFORM-HF","Inclusion Criteria:\n\n1. Age ≥21 years and \\\u003C 80 years\n2. Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .\n3. No change in diuretic dosage in the past 5 days\n4. Subjects with eGFR between 15-89 mL\u002Fmin\u002F1.73m2\n5. Baseline NT-proBNP ≥600 pg\u002FmL\n6. Baseline systolic blood pressure ≥100 mmHg\n7. Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation\n8. Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study\n\nExclusion Criteria:\n\n1. Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .\n2. Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure\n3. Known allergy to Polyester or Thermoplastic polyurethane (TPU)\n4. Subject with severe peripheral arterial disease\n5. Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.\n6. Subject with known hypothalamic disorders\n7. Subject with known hypohidrosis disorders\n8. Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)\n9. Subject with cystic fibrosis\n10. Subject with active infections\n11. Inability or unwillingness to comply with the study requirements\n12. Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)\n13. Known Severe aortic valve or mitral valve stenosis\n14. History of a heart transplant or actively listed for a heart transplant\n15. Implanted left ventricular assist device (LVAD) or implant anticipated in \\\u003C3 months\n16. Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities","ALL","21 Years","79 Years",{"count":236,"type":237},40,"ESTIMATED","INTERVENTIONAL",[240],"NA","The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.\n\nPatients will wear a lightweight suit that helps remove excess fluids through their sweat.\n\nThe investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.\n\nParticipants will be treated in the hospital or in the outpatient clinic.",[243,244],"Chronic Heart Failure","CKD Stage 3",[246,247,248,249],"Aquapass","Sweat Enhancement","Fluid removal","CHF","2026-07-02",{"date":252,"type":253},"2026-07-06","ACTUAL",{"date":255,"type":253},"2024-08-12",{"date":257,"type":237},"2027-04",{"name":5,"class":6},10]