[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373998":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":76,"collaborators":78,"id":84,"slug":12,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":12,"enrollmentInfo":93,"targetDuration":12,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":12,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Aventusoft, LLC.","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized Standard of Care","NO_INTERVENTION","Standard of Care",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Randomized Standard of Care with HEMOTAG","ACTIVE_COMPARATOR","Standard of Care with HEMOTAG",[18],"Diagnostic Test: Standard of Care with Hemotag",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Standard of Care with Hemotag","Comparison of outcomes",[14],[11],[27],{"name":28,"affiliation":29,"role":30},"David Snipelisky, MD","Cleveland Clinic Florida","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Cindy Kober","CONTACT","561-945-9303","cindy@aventusoft.com",{"name":38,"role":34,"phone":39,"phoneExt":12,"email":40},"Kaustubh Kale","954-399-3335","kaustubh@aventusoft.com",[42,61],{"facility":29,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Weston","Florida","33331","United States",{"type":49,"coordinates":50},"Point",[51,52],-80.39977,26.10037,{"lat":52,"lon":51},[55,57,59],{"name":56,"role":34,"phone":12,"phoneExt":12,"email":12},"Diana Yanez, BSN,RN",{"name":58,"role":34,"phone":12,"phoneExt":12,"email":12},"Cecilia Calvo",{"name":60,"role":30,"phone":12,"phoneExt":12,"email":12},"David Snipelisky",{"facility":62,"status":43,"city":63,"state":64,"zip":65,"country":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Baylor Scott & White Research Institute","Temple","Texas","76508",{"type":49,"coordinates":67},[68,69],-97.34278,31.09823,{"lat":69,"lon":68},[72,74],{"name":73,"role":34,"phone":12,"phoneExt":12,"email":12},"Amy M Watts, BSN,RN",{"name":75,"role":30,"phone":12,"phoneExt":12,"email":12},"Jamie Hernandez-Montfort, MD",{"type":77,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[79,82],{"name":80,"class":81},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":29,"class":83},"OTHER","100373998",false,"NCT04149743","HEMOTAG® Assessment for Short-term Outcomes of Heart Failure","HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]","HATS-OFF","Inclusion Criteria:\n\n* Age greater than or equal to 22 years old.\n* An index hospital admission for ADHF presenting with symptoms, clinical signs, and chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or vasoactive drugs and having a BNP \\> 350 or NT-pro BNP \\> 1800 pg\u002Fml.\n* Able to give informed consent.\n* Participant's residence has adequate cellular data coverage.\n* Participants with previous diagnosis of left ventricular ejection fraction (LVEF) \\\u003C40% prior to the index hospitalization must have been treated for at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or contraindicated).\n\nExclusion Criteria:\n\n* Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)\n* Terminal condition with life expectancy less than 6 months as determined by investigator.\n* Participants with cardiac tamponade or constrictive pericarditis.\n* Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation.\n* Implantation of a CRT (cardiac resynchronization therapy) device during index hospitalization or intent to implant a CRT device.\n* Presence of hemodynamically significant mitral and\u002For aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation, as determined by investigator.\n* Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis, as determined by investigator.\n* Severe primary pulmonary, renal or hepatic disease, as determined by investigator.\n* Women of childbearing age (Age \\\u003C50).\n* History of pulmonary embolism of less than 3 months.\n* Dialysis dependent or dialysis initiation expected within three months.\n* Chronic home IV therapy or cardiac inotropes or diuretics.\n* Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.\n* Illness\u002F Condition which may be aggravated or cause significant discomfort by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).\n* Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.\n* Congenital heart malformations (Complex, or uncorrected congenital heart disease).\n* Participant enrolled in another interventional study (observational or registries are not excluded).\n* Participant HF is managed remotely with another monitoring device or program (for example: Pulmonary\u002F Lt Atrial pressure monitoring, lung fluid monitoring. BNP\u002Fpro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance monitoring will be allowed unless it is part of another research protocol).\n* Prisoners and wards of the state.\n* Inability to provide informed consent (Must speak English or Spanish or Creole).","ALL","22 Years",{"count":94,"type":95},420,"ESTIMATED","INTERVENTIONAL",[98],"NA","Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.",[101],"Heart Failure (HF)","2024-08-19",{"date":104,"type":105},"2024-08-21","ACTUAL",{"date":107,"type":105},"2022-01-31",{"date":109,"type":95},"2024-12",{"name":5,"class":6},2]