[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494919":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":41,"studyPopulation":31,"armGroups":42,"interventions":54,"overallOfficials":63,"centralContacts":68,"locations":78,"responsibleParty":196,"collaborators":199,"id":203,"slug":31,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":204,"sex":210,"minAge":211,"maxAge":31,"enrollmentInfo":212,"targetDuration":31,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":81,"whyStopped":31,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary \"Hierarchical\" Composite Outcome of:","1. Target dose of BB, ARNI or ACEi\u002FARB, MRA, and SGLT2i at 90 days\n2. GDMT intensification at 30 days, defined as (a) initiation or up-titration of beta-blocker; (b) switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol; (c) initiation or up-titration of ACEi\u002FARB or ARNI; (d) switch from ACEi\u002FARB to ARNI; (e) initiation or up-titration of MRA; or (f) initiation of SGLT2i\n3. Change in health status, as measured by the KCCQ-12 summary score at 90 days\n\nPLEASE NOTE: THESE ARE \"HIERACHIAL OUTCOMES\"","30 and 90 days",{"measure":14,"description":15,"timeFrame":16},"Co-primary \"Hierarchical\" Composite Outcome of:","1. All cause death at 180 days\n2. HF hospitalization at 180 days\n3. All-cause ED visit at 180 days\n4. Change in KCCQ-12 summary score at 90 days\n\nPLEASE NOTE: THESE ARE \"HIERACHIAL OUTCOMES\"","90 and 180 days",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"GDMT use","Achievement of at least 50% of the target doses of BB, ACEi\u002FARB or ARNI, MRA, SGLT2i at 90 days.","90 days",{"measure":23,"description":24,"timeFrame":25},"Clinical Outcomes","i) Time to composite all-cause death, HF hospitalization, or all-cause ED visit at 180 days ii) Components of composite endpoint\n\n* Time to all-cause death\n* Time to HF hospitalization\n* Time to all-cause ED visit iii) Change in health status (KCCQ-12 summary score) at 90 days","90 days and 180 days",{"measure":27,"description":28,"timeFrame":25},"Healthcare utilization","i) direct healthcare cost at 90 and 180 days",{"measure":27,"description":30,"timeFrame":25},"ii) number of virtual and in-person clinic visits per patient in 90 days.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"RANDOMIZED","PARALLEL","This is an unblinded parallel multi-center Randomized Controlled Trial (RCT) of virtual HF clinics + routine care versus routine care alone in patients discharged after a hospitalization or urgent\u002Femergency visit for HF. Randomization will be at the level of the patients and stratified by hospital site.\n\nPatients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.","HEALTH_SERVICES_RESEARCH",{"masking":38,"maskingDescription":31,"whoMasked":39},"SINGLE",[40],"OUTCOMES_ASSESSOR","Heart failure (HF) is a leading cause of death, hospitalization, and healthcare system expenditure in Canada. While care in HF clinics - multidisciplinary clinics that focus on optimal management of HF - improves health outcomes in HF, there are disparities in access to such care across our province. To respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable Canadians with HF to receive outpatient HF care and medical optimization remotely. The investigators hypothesize that relative to routine care alone, virtual HF clinics will improve a composite of implementation and clinical outcomes.\n\nA pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. Data collection during the pilot phase focused on the process outcomes approved by HiREB (ID 5441).",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Virtual HF care","EXPERIMENTAL","Patients will receive virtual HF care to optimize medical therapies",[48],"Other: Virtual HF Care",{"label":50,"type":6,"description":51,"interventionNames":52},"Routine HF care","Participants will receive routine HF care",[53],"Other: Routine HF Care",[55,59],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":31},"Virtual HF Care","Patients will receive virtual visits for 3 months following hospitalization \u002F emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.",[44],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":31},"Routine HF Care","Care as determined by the treating physician",[50],[64],{"name":65,"affiliation":66,"role":67},"Harriette Van Spall, MD","McMaster University","PRINCIPAL_INVESTIGATOR",[69,75],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Harriette GC Van Spall, MD MPH","CONTACT","(905) 521-2100","40601","Harriette.VanSpall@phri.ca",{"name":76,"role":71,"phone":31,"phoneExt":31,"email":77},"VICTORY-HF Project office","victory-hf@phri.ca",[79,96,106,115,129,142,157,170,183],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"St. Joseph's Healthcare Hamilton","RECRUITING","Hamilton","Onatrio","L8N 4A6","Canada","CA",{"type":88,"coordinates":89},"Point",[90,91],-79.84963,43.25011,{"lat":91,"lon":90},[94],{"name":95,"role":71,"phone":31,"phoneExt":31,"email":31},"Katie Connolly, Dr",{"facility":97,"status":81,"city":82,"state":98,"zip":99,"country":85,"countryCode":86,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Hamilton General Hospital","Ontario","L8L 2X2",{"type":88,"coordinates":101},[90,91],{"lat":91,"lon":90},[104],{"name":105,"role":71,"phone":31,"phoneExt":31,"email":31},"Harriette Van Spall, Dr",{"facility":107,"status":81,"city":82,"state":98,"zip":108,"country":85,"countryCode":86,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"Juravinski Hospital Cancer Centre","L8V 5C2",{"type":88,"coordinates":110},[90,91],{"lat":91,"lon":90},[113],{"name":114,"role":71,"phone":31,"phoneExt":31,"email":31},"Serena Gundy, Dr.",{"facility":116,"status":117,"city":118,"state":98,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Thunder Bay Regional Health Sciences Centre","NOT_YET_RECRUITING","Thunder Bay",{"type":88,"coordinates":120},[121,122],-89.25018,48.38202,{"lat":122,"lon":121},[125],{"name":126,"role":71,"phone":127,"phoneExt":31,"email":128},"Vahid Akbari","807-684-7580","Vahid.Akbari@tbh.net",{"facility":130,"status":117,"city":131,"state":98,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Unity Health Toronto","Toronto",{"type":88,"coordinates":133},[134,135],-79.39864,43.70643,{"lat":135,"lon":134},[138],{"name":139,"role":71,"phone":140,"phoneExt":31,"email":141},"Peter Mitoff","416-766-1162","Peter.Mitoff@unityhealth.to",{"facility":143,"status":81,"city":144,"state":31,"zip":31,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Fattouma Bourguiba Hospital","Monastir","Tunisia","TN",{"type":88,"coordinates":148},[149,150],10.82617,35.77799,{"lat":150,"lon":149},[153],{"name":154,"role":71,"phone":155,"phoneExt":31,"email":156},"Semir Nouira","+21673106000","semir.nouira@rns.tn",{"facility":158,"status":81,"city":159,"state":31,"zip":31,"country":145,"countryCode":146,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Hedi Chaker Hospital","Sfax",{"type":88,"coordinates":161},[162,163],10.76028,34.74056,{"lat":163,"lon":162},[166],{"name":167,"role":71,"phone":168,"phoneExt":31,"email":169},"Leila Abid","+21674244511","leilaabidt@yahoo.fr",{"facility":171,"status":81,"city":172,"state":31,"zip":31,"country":145,"countryCode":146,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Sahloul Hospital","Sousse",{"type":88,"coordinates":174},[175,176],10.63699,35.82539,{"lat":176,"lon":175},[179],{"name":180,"role":71,"phone":181,"phoneExt":31,"email":182},"Riadh Boukef","+21673369411","riadboukef@gmail.com",{"facility":184,"status":81,"city":185,"state":31,"zip":31,"country":145,"countryCode":146,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Military Hospital","Tunis",{"type":88,"coordinates":187},[188,189],10.16579,36.81897,{"lat":189,"lon":188},[192],{"name":193,"role":71,"phone":194,"phoneExt":31,"email":195},"Wafa Fehri","+21671391133","wafafehri@gmail.com",{"type":67,"investigatorFullName":197,"investigatorTitle":198,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Harriette Van Spall","Assistant Professor of Medicine, Division of Cardiology, McMaster University, Population Health Research Institute",[200,202],{"name":201,"class":6},"Hamilton Health Sciences Corporation",{"name":66,"class":6},"100494919",false,"NCT05724433","VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization","VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT","VICTORY-HF","Inclusion Criteria:\n\nAdult patients ≥ 18 years old who:\n\n1. Are being discharged after hospitalization or urgent visit for HF as\n\n   1. a primary diagnosis or\n   2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.\n2. Have left ventricular ejection fraction (LVEF) \\\u003C 50% within the preceding 3 months.\n3. Have NT-proBNP of \\> 900 pg\u002Fml during hospital admission or within 7 days after discharge from the ED\n4. Have a mailing address for patient or caregiver\n5. Provide verbal consent\n\nExclusion Criteria:\n\n1. Died or left hospital before medically advised hospital discharge\n2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)\n3. Unable to engage with digital health technology or follow up\n4. Severe valve disease\n5. Recipient of or on waiting list for LVAD or cardiac transplant\n6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy\n7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) \\\u003C 1 litre, severe pulmonary hypertension with RVSP \\> 60 mm Hg, or on home oxygen\n8. Severe kidney disease (persistent eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2)\n9. Active malignancy\n10. Receiving palliative care or expected life expectancy \\\u003C 6 months","ALL","18 Years",{"count":213,"type":214},891,"ESTIMATED","INTERVENTIONAL",[217],"NA","The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.",[220],"Heart Failure",[220,222,223,224],"Randomized Controlled Trial","Digital Health","Knowledge Translation","2024-12-27",{"date":227,"type":228},"2024-12-31","ACTUAL",{"date":230,"type":228},"2023-01-23",{"date":232,"type":214},"2026-12-31",{"name":5,"class":6},9]