[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554609":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":24,"collaborators":28,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Semmelweis University Heart and Vascular Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation with active device","ACTIVE_COMPARATOR",null,[13],"Device: Photobiomodulation",{"label":15,"type":16,"description":11,"interventionNames":17},"Control with Sham device","SHAM_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Photobiomodulation","Soft laser therapy",[15,9],{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Annamaria Kosztin MD, PhD","Principal Investigator",[29],{"name":30,"class":31},"Laser Light Medical Innovations Ltd.","UNKNOWN","100554609","photobiomodulation-for-patients-with-advanced-heart-failure-100554609",false,"NCT06501313","PhotobiomoduLation for pAtientS With Advanced hEart failuRe","LASER","Inclusion Criteria:\n\nAdvanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form\n\nExclusion Criteria:\n\nNon-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial","ALL","18 Years",{"count":42,"type":43},70,"ESTIMATED","INTERVENTIONAL",[46],"NA","The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.",[49,50],"Heart Failure With Reduced Ejection Fraction","Heart Failure, Systolic","NOT_YET_RECRUITING","2024-07-08",{"date":54,"type":55},"2024-07-15","ACTUAL",{"date":57,"type":43},"2024-08-01",{"date":59,"type":43},"2026-05-01",{"name":5,"class":6}]