[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AquaPass Medical Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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\n* Age ≥21 years and \\\u003C 80 years\n* Patient, with known decompensated heart failure and\u002For CKD stage 2 or more 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 40 mg furosemide or greater or the equivalent dose of another loop diuretic.\n* Patients with no Heart Failure related hospitalization in the past 30 days\n* No change in diuretic regimen in the past 7 days\n* Baseline NT-proBNP ≥600 pg\u002FmL\n* Baseline systolic blood pressure ≥100 mmHg\n* Patient 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\n* Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study\n\nExclusion Criteria:\n\n* Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.\n* Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)\n* Patient with severe peripheral arterial disease\n* Patient is pregnant or planning to become pregnant within the study period, or a lactating woman.\n* Renal disease with eGFR \\\u003C25 ml\u002Fmin\u002F1.73 m2\n* Patients with known hypothalamic disorders\n* Patients with known hypohidrosis disorders\n* Patients with medical technology dependency (gastric (G) tubes, ventilators etc.)\n* Patients with cystic fibrosis\n* Patients with active infections\n* Inability or unwillingness to comply with the study requirements\n* Patients with unstable electrolytes or acid-base balance (per investigator's discretion)\n* Known Severe aortic valve or mitral valve stenosis\n* History of a heart transplant or actively listed for a heart transplant or LVAD\n* Implanted left ventricular assist device or implant anticipated \\\u003C3 months\n* Patients with an active, malignant disease and whose life expectancy is \\\u003C 6 months (per investigator's discretion)\n* Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)","ALL","21 Years","80 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"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 select if to be treated at their home or in the outpatient clinic.",[28,29],"Chronic Heart Failure","CKD Stage 3",[31,32,33,34],"Aquapass","Sweat Enhancement","Fluid removal","CHF","RECRUITING","2024-09-17",{"date":38,"type":39},"2024-09-19","ACTUAL",{"date":41,"type":39},"2024-09-05",{"date":43,"type":22},"2025-01-29",{"name":45,"class":46},"AquaPass Medical Ltd.","INDUSTRY",4,""]