[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Levothyroxine","EXPERIMENTAL","Patients will be double-blinded and randomized to receive levothyroxine.",[13],"Drug: Levothyroxine",{"label":15,"type":16,"description":17,"interventionNames":18},"No Levothyroxine","PLACEBO_COMPARATOR","Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.",[19],"Drug: Normal saline",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dosing will be based on pre-existing protocols in the setting of organ donation.This will be the protocol for the first 18-38 hours starting intra-operatively after the donated heart is sewn in.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Normal saline","Placebo will be normal saline and will be dosed at the same rate and time as the study drug.",[15],[31],{"name":32,"affiliation":5,"role":33},"Jason Smith, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Sarah Sullivan","CONTACT","415-353-7083","Sarah.sullivan2@ucsf.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","San Francisco","California","94143","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.41942,37.77493,{"lat":52,"lon":51},[55,56],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100548984","phase-1-levothyroxine-supplementation-for-heart-transplant-recipients-100548984",false,"NCT06428097","Levothyroxine Supplementation for Heart Transplant Recipients","Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial","Levo","Inclusion Criteria:\n\n1. Participants must be listed for heart transplantation\n2. Age ≥18 years\n3. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy\n2. Patients with a known allergy or intolerance to levothyroxine\n3. Patients participating in another study evaluating an investigational drug within the past 30 days.","ALL","18 Years",{"count":70,"type":71},97,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.",[77,78],"Heart Transplant Failure","Heart Transplant Infection","2025-04-28",{"date":81,"type":82},"2025-05-01","ACTUAL",{"date":84,"type":82},"2024-03-29",{"date":86,"type":71},"2027-03-01",{"name":5,"class":6},1]