[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620227":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":26,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":26},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trizepatide","ACTIVE_COMPARATOR","Tirzepatide (Munjaro), starting dose 2,5 mg subcutaneous weekly for 4 weeks, dosage increased monthly for 2.5 mg according to study protocol, based on clinical response and tolerability.",[13],"Drug: Treatment with tirzapatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo 0.9% saline via identical pens administrated subcutaneous once weekly, same as active comparator, according to the same study protocol",[19],"Drug: Treatment with placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Treatment with tirzapatide","Treatment with tirzepatide for 6 months, starting dosage 2,5 mg subcutaneous. Titration every 4 weeks by 2,5 mg increase, based on clinical response and tolerability of adverse effects, up to a maximum dose of 15 mg.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Treatment with placebo","Treatment with palcebo for 6 months, 0.9% saline via administrated via identical pens subcutaneous once weekly, same as active comparator, according to the same study protocol.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Andrej Janež, Prof., MD, PhD","University Medical Centre Ljubljana, Slovenia","STUDY_DIRECTOR",{"name":37,"affiliation":38,"role":39},"Margarita Brida, Ass. prof., MD, PhD","Royal Brompton Hospital, London, UK","STUDY_CHAIR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Katja Prokšelj, Assoc. prof., MD, PhD","CONTACT","+386 1 522 85 72","katja.prokselj@kclj.si",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Andrej Janež, Prof., MD. PhD","+ 386 1 522 35 64","andrej.janez@kclj.si",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Katja Prokselj","Assoc. prof., senior consultant","100620227","phase-4-effect-of-tirzepatide-on-cardiovascular-and-metabolic-parameters-in-obese-adult-patients-with-congenital-heart-disease-100620227",false,"NCT07354880","Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease","TEACH","Inclusion Criteria:\n\n* Obese or overweight adult patients with congenital heart disease\n* BMI between 30 kg\u002Fm² and 40 kg\u002Fm²\n* Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%\n* Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)\n* No prior pharmacological or surgical interventions for obesity\n* Euthyroid state\n* Eumenorrhea or oligomenorrhea\n* Ability to comprehend the study objectives and procedures\n* Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate\n* Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment.\n\nExclusion Criteria:\n\n* Down syndrome\n* Type 2 diabetes\n* Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle \\\u003C 30%, malignant arrhythmias, severe heart valve disease\n* Personal history of malignancy, personal or family history of medullary thyroid carcinoma\n* Personal history of pancreatitis or cholelithiasis\n* Personal history of acute coronary events or hemodynamically significant coronary artery disease\n* Current treatment with sympathomimetics or sympatholytic\n* Psychiatric disorders, personal history of depressive disorders or suicidal ideation\n* Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods\n* Excessive alcohol consumption\n* Smoking","ALL","18 Years","70 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD.\n\nIn a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.",[72,73],"Obesity & Overweight","Adult Congenital Heart Disease",[75,76,77,78,79],"Obesity","adult congenital heart disease","tirzepatide","cardiovascular factors","metabolic factors","NOT_YET_RECRUITING","2026-01-18",{"date":83,"type":84},"2026-01-21","ACTUAL",{"date":86,"type":66},"2026-01-20",{"date":88,"type":66},"2027-12-31",{"name":5,"class":6}]