[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649793":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":38,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":31,"enrollmentInfo":56,"targetDuration":31,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":31},{"fullName":5,"class":6},"Shahid Beheshti University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide","EXPERIMENTAL","Participants receive tirzepatide via prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy. Starting dose is 2.5 mg once weekly for 4 weeks, titrated based on tolerability every 4 weeks up to a maximum of 10 mg once weekly, continued through month 6.",[13],"Drug: Tirzepatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo via identical prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy, with the same dosing schedule and titration pattern as the tirzepatide group, continued through month 6.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","dual GLP-1\u002FGIP receptor agonist administered subcutaneously; brief dosing summary",[9],[26],"Spartina",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Matching placebo pen containing all inactive ingredients except tirzepatide",[15],[26],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Shadi Shafaghi, MD-MPH-PhD","CONTACT","989125901135","shafaghishadi@yahoo.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Shadi Shafaghi","Principal Investigator, Assistant Professor of Biotechnology.",[43],{"name":44,"class":45},"Cinnagen","INDUSTRY","100649793","phase-3-evaluation-of-the-efficacy-and-safety-of-tirzepatide-a-dual-glp-1gip-agonist-on-functional-capacity-in-reduced-ejection-fraction-heart-failure-patients-with-obesity-100649793",false,"NCT07738276","Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1\u002FGIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity","Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1\u002FGIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity: A Double-Blinded Randomized Controlled Trial","DUAL-HFrEF","Inclusion Criteria:\n\n* Age 18 years or older\n* Heart failure with reduced ejection fraction, defined as left ventricular ejection fraction ≤40% on echocardiography performed within the prior 3 months\n* Body mass index ≥27 kg\u002Fm², with at least one obesity-related comorbidity (hypertension, diabetes, or dyslipidemia)\n* Stable heart failure therapy for at least 4 weeks prior to enrollment, including beta-blockers, renin-angiotensin system inhibitors\u002Fangiotensin receptor-neprilysin inhibitors, and sodium-glucose cotransporter-2 inhibitors, if prescribed\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute heart failure decompensation or cardiac hospitalization within the prior 4 weeks\n* Uncontrolled blood pressure (systolic blood pressure \\\u003C90 mmHg or ≥180 mmHg)\n* Advanced renal impairment (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic impairment (liver enzymes elevated to 3 times the upper limit of normal)\n* Active pancreatitis\n* Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n* Pregnancy or breastfeeding\n* Known hypersensitivity to glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist drugs\n* Concurrent use of other weight-loss medications","ALL","18 Years",{"count":57,"type":58},60,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","The goal of this clinical trial is to learn if tirzepatide works to improve physical function in adults with heart failure and obesity. It will also learn about the safety of tirzepatide. The main questions it aims to answer are:\n\nDoes tirzepatide improve how far participants can walk in 6 minutes? Does tirzepatide improve heart failure symptoms and quality of life? What side effects do participants have when taking tirzepatide?\n\nResearchers will compare tirzepatide to a placebo (a look-alike substance that contains no drug) to see if tirzepatide improves physical function in people with heart failure and obesity.\n\nParticipants will:\n\nGet a weekly injection of tirzepatide or a placebo under the skin for 6 months Start at a low dose, which may be raised slowly based on how well they tolerate it Keep taking their usual heart failure medicines Visit the clinic for checkups, blood tests, heart ultrasounds, and a 6-minute walk test Answer questions about their quality of life and heart failure symptoms",[64,65,9],"Heart Failure and Reduced Ejection Fraction","Obesity & Overweight",[9,67,68,69,70,71,72,73],"GLP-1\u002FGIP receptor agonist","Heart failure with reduced ejection fraction","Obesity","6-minute walk test","Weight loss","Functional capacity","Randomized controlled trial","NOT_YET_RECRUITING","2026-07-30",{"date":77,"type":78},"2026-08-03","ACTUAL",{"date":80,"type":58},"2026-07-18",{"date":82,"type":58},"2027-12-22",{"name":5,"class":6}]