[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100401203":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":87,"collaborators":31,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":31,"enrollmentInfo":98,"targetDuration":31,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":31,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Zoll Medical Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Heart Rate Monitor Enhanced Treatment Optimization","EXPERIMENTAL","Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.",[13],"Device: Heart Rate Monitor Enhanced Treatment Optimization",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.",[9],[20],"LifeVest Wearable Cardioverter Defibrillator",[22],{"name":23,"affiliation":24,"role":25},"Valentina Kutyifa, MD PHD","University of Rochester","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Mike Osz","CONTACT","412-968-3333",null,"mosz@zoll.com",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Tara Roberts","tara.roberts@zoll.com",[37,54,65,77],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"TriHealth Hatton Research Institute","RECRUITING","Cincinnati","Ohio","45242","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-84.51439,39.12711,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":31,"phoneExt":31,"email":31},"Kesari, MD",{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":31},"Texas Cardiology Associates of Houston","TERMINATED","Kingwood","Texas","77339",{"type":46,"coordinates":61},[62,63],-95.18349,30.05691,{"lat":63,"lon":62},{"facility":66,"status":39,"city":67,"state":58,"zip":68,"country":43,"countryCode":44,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"CardioVoyage","McKinney","75020",{"type":46,"coordinates":70},[71,72],-96.61527,33.19762,{"lat":72,"lon":71},[75],{"name":76,"role":29,"phone":31,"phoneExt":31,"email":31},"Abo-Auda, MD",{"facility":78,"status":56,"city":79,"state":80,"zip":81,"country":43,"countryCode":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":31},"CAMC","Charleston","West Virginia","25304",{"type":46,"coordinates":83},[84,85],-81.63262,38.34982,{"lat":85,"lon":84},{"type":88,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100401203","optimizing-beta-blocker-dosage-in-women-while-using-the-wearable-cardioverter-defibrillator-100401203",false,"NCT04504188","Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator","OPT-BB WOMEN","Inclusion Criteria for Screening Phase:\n\n* Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription.\n* Patients prescribed the WCD for an intended 90 ± 14 days of use.\n* Patients have used the WCD for no more than 14 days from the day of consent.\n* Patients 18 years of age or older at the time of consent.\n\nInclusion Criteria for Continuation Phase:\n\n-After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours\u002Fday) are eligible to continue.\n\nExclusion Criteria for Screening Phase:\n\n* Patients with a known contraindication or intolerance to beta-blocker therapy.\n* Patients with permanent atrial fibrillation.\n* Patients who have a pacemaker.\n* Patients with a current or prior implantable cardioverter defibrillator (ICD).\n* Patients who are self-reporting to be pregnant.\n* Patients with known congenital or inherited heart disease.\n* Patients participating in another interventional clinical trial.\n* Patients not expected to live longer than 3 months.\n\nExclusion Criteria for Continuation Phase:\n\n-Patients ending WCD use within the first two weeks of use.","FEMALE","18 Years",{"count":99,"type":100},300,"ESTIMATED","INTERVENTIONAL",[103],"NA","The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR \\\u003C 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB\u002Fivabradine dosage, as compared to a prior historical control.",[106,107],"Cardiomyopathies","Heart Failure","2024-07-23",{"date":110,"type":111},"2024-07-24","ACTUAL",{"date":113,"type":111},"2021-03-08",{"date":115,"type":100},"2024-12",{"name":5,"class":6},4]