[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628353":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":20,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":21,"locations":27,"responsibleParty":60,"collaborators":11,"id":64,"slug":11,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":11,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"LMU Klinikum","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Time to first heart failure related hospitalization",null,"3 years",{"measure":14,"description":11,"timeFrame":12},"Time to death from any cause",{"measure":16,"description":11,"timeFrame":12},"Time to cardiovascular death",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":18,"timePerspective":19,"maskingInfo":11},"COHORT","PROSPECTIVE","Participating hospitals",[22],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Stefan Brunner, MD","CONTACT","+49 89 4400 0","Stefan.Brunner@med.uni-muenchen.de",[28,45],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"LMU University Hospital","RECRUITING","Munich","Bavaria","80336","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],11.57549,48.13743,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":25,"phoneExt":11,"email":26},"Brunner, MD",{"facility":46,"status":30,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Central Hospital of Bolzano","Bolzano","Italy","IT",{"type":37,"coordinates":51},[52,53],11.33982,46.49067,{"lat":53,"lon":52},[56],{"name":57,"role":24,"phone":58,"phoneExt":11,"email":59},"Matthias Unterhuber, MD","+39 0471 439 950","kardiologie.bz@sabes.it",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Stefan Brunner","Principal Investigator","100628353",false,"NCT07460531","Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure","SOPHIE","Inclusion Criteria:\n\n* Heart failure NT-proBNP \\>600 pg\u002Fml (at least once in the history) NYHA-Class II-IV HFrEF - heart failure with reduced ejection fraction; LVEF ≤40% or HFmrEF - heart failure with mildly reduced ejection fraction; LVEF 41% - 49% or HFpEF - heart failure with preserved ejection fraction; LVEF ≥50%\n* Age ≥18 years old\n* Willingness to participate in the study, confirmed by a signed informed consent form\n* Ownership of a pedometer (e.g. smartwatch, activity tracker, smartphone-app, analogical pedometer)\n\nExclusion Criteria:\n\n* Disease or disability that prevents physical activity\n* Hospitalisation due to heart failure within the last three months","ALL","18 Years",{"count":73,"type":74},2000,"ESTIMATED","3 Years","OBSERVATIONAL","SOPHIE is a prospective, multicentre, observational cohort study aiming to enrol 2,000 CHF patients. Baseline assessments include validated PA questionnaires (GPAQ, IPAQ, KCCQ) and seven-day step counts from commercially available pedometer devices. Follow-up is conducted every six months via telephone, repeating PA assessments and recording cardiovascular events, hospitalisations, and patient-reported outcomes.",[79],"Heart Failure","2026-03-09",{"date":82,"type":83},"2026-03-11","ACTUAL",{"date":85,"type":83},"2025-02-01",{"date":87,"type":74},"2031-06-30",{"name":5,"class":6},2]