[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658449":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":36,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":81,"collaborators":13,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":13,"enrollmentInfo":95,"targetDuration":13,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":105,"whyStopped":13,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Cardiac Troponin Assessment","The principal biochemical endpoint will be defined as:\n\nCardiac troponin concentration \\>99th percentile upper reference limit of the laboratory assay.\n\nAcute myocardial injury will be characterized by a dynamic rise and\u002For fall in troponin when clinically appropriate.","3 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Prospective, randomized, controlled, parallel-group, open-label clinical trial with blinded laboratory and cardiac imaging assessment.","PREVENTION",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","Because linagliptin administration is readily identifiable, the study will be open-label with respect to patients and treating investigators.\n\nHowever:\n\n* Laboratory personnel assessing cardiac troponin should be blinded to treatment allocation.\n* Echocardiographers should be blinded whenever feasible.\n* Statistical analysis should be performed using coded treatment groups.\n* Adjudication of cardiac outcomes should preferably be performed by investigators blinded to treatment assignment.","1\\. Background and Rationale Breast cancer is one of the most common malignancies affecting women worldwide and represents a major health burden in Egypt. Anthracyclines, particularly doxorubicin, remain an important component of several breast cancer chemotherapy regimens. However, their clinical utility is limited by the potential development of anthracycline-induced cardiotoxicity.\n\nDoxorubicin-induced cardiac injury is multifactorial and involves oxidative stress, mitochondrial dysfunction, disturbances in myocardial energy metabolism, apoptosis, inflammation, and progressive myocardial structural damage. Cardiac injury may initially occur without symptoms or an obvious reduction in left ventricular ejection fraction (LVEF). Consequently, identification of early myocardial injury is important because intervention before clinically apparent heart failure may potentially reduce progression to overt cardiac dysfunction.\n\nThe European Society of Cardiology recommends cardiovascular assessment and surveillance in patients receiving potentially cardiotoxic cancer therapies. Cardiac troponin (cTn) and natriuretic peptides may be used as biomarkers of cancer therapy-related cardiovascular toxicity, while echocardiography, including LVEF and global longitudinal strain (GLS) where available, provides complementary information about cardiac function.\n\nCardiac troponin is a highly specific biomarker of myocardial injury. According to the Fourth Universal Definition of Myocardial Infarction, myocardial injury is defined by a cardiac troponin concentration above the assay-specific 99th-percentile upper reference limit, while an acute injury is characterized by a rise and\u002For fall in troponin values.\n\nDipeptidyl peptidase-4 (DPP-4) inhibitors are primarily used as glucose-lowering agents in patients with type 2 diabetes mellitus. Linagliptin is a selective DPP-4 inhibitor administered at a standard dose of 5 mg once daily. Large cardiovascular-outcome data have demonstrated cardiovascular safety of linagliptin in patients with type 2 diabetes at high cardiovascular and renal risk, including no significant increase in hospitalization for heart failure compared with placebo.\n\nHowever, whether linagliptin can prevent anthracycline-associated myocardial injury in women with breast cancer without diabetes remains insufficiently established. This creates a clinically relevant research gap.\n\nTherefore, the proposed study will investigate whether prophylactic linagliptin, administered during doxorubicin-containing chemotherapy, can attenuate biochemical evidence of myocardial injury assessed by cardiac troponin and reduce the development of cardiac dysfunction.",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Arm A (Control)","PLACEBO_COMPARATOR","Participants will receive standard oncological care without prophylactic linagliptin.",[29],"Drug: Doxorubicin",{"label":31,"type":32,"description":33,"interventionNames":34},"Arm B (Linagliptin)","EXPERIMENTAL","Participants will receive:\n\nLinagliptin 5 mg orally once daily. The proposed treatment will begin before or at initiation of the first doxorubicin-containing chemotherapy cycle and continue throughout the predefined chemotherapy period.",[29,35],"Drug: Empaglifloz 5 mg orally once daily",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DRUG","Doxorubicin","Standard oncologic care without cardioprotective intervention followed concurrently for 24 weeks",[25,31],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"Empaglifloz 5 mg orally once daily","Initiated 1 week prior to chemotherapy; continued for 24 weeks",[31],[47],{"name":48,"affiliation":49,"role":50},"Haidy Mahmoud Sami, Lecturer","Delta University","STUDY_DIRECTOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Mai Aboelyazed El-Gebaly, Associate Lecturer","CONTACT","+0201061412257","020","dr.mai.elgebaly@gmail.com",{"name":59,"role":54,"phone":60,"phoneExt":56,"email":57},"Mai Aboelyazed Elgebaly, Associate Lecturer","+201115064114",[62],{"facility":5,"status":13,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Tanta","Elgharbeya","GHR","Egypt","EG",{"type":69,"coordinates":70},"Point",[71,72],31.00192,30.78847,{"lat":72,"lon":71},[75,77,79],{"name":53,"role":54,"phone":76,"phoneExt":56,"email":57},"010-6141-2257",{"name":59,"role":54,"phone":78,"phoneExt":56,"email":57},"011-1506-4114",{"name":48,"role":80,"phone":13,"phoneExt":13,"email":13},"SUB_INVESTIGATOR",{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mai Abo Elyazeed Hassan Hamouda","Associate Lecturer","100658449","phase-3-cardioprotection-effect-of-linagliptin-100658449",false,"NCT07852546","Cardioprotection Effect of Linagliptin","Cardio-protective Effect of Linagliptin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy","Linagliptin","Inclusion Criteria:\n\n* 1\\. Female patients aged ≥18 years. 2. Egyptian nationality. 3. Histologically confirmed breast cancer. 4. Planned treatment with a doxorubicin-containing chemotherapy regimen. 5. Expected cumulative doxorubicin dose of approximately ≥240 mg\u002Fm², or another prespecified protocol threshold.\n\n  6\\. Baseline LVEF ≥53%. 7. Adequate baseline echocardiographic assessment. 8. Baseline cardiac troponin below the laboratory's predefined exclusion threshold.\n\n  9\\. Ability to take oral medication. 10. Ability to provide written informed consent. 11. Willingness to comply with study visits, blood sampling and cardiac assessments.\n\nExclusion Criteria:\n\n* 1\\. Previous exposure to anthracyclines. 2. Known heart failure. 3. Baseline LVEF \\\u003C53%. 4. Previous myocardial infarction or significant coronary artery disease. 5. Significant valvular heart disease. 6. Clinically significant arrhythmia. 7. Uncontrolled hypertension. 8. Significant renal impairment according to a predefined eGFR threshold. 9. Significant hepatic impairment. 10. Active infection or another condition likely to affect troponin interpretation.","FEMALE","18 Years",{"count":96,"type":97},140,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","1\\. Background and Rationale Breast cancer is one of the most common malignancies affecting women worldwide and represents a major health burden in Egypt. Anthracyclines, particularly doxorubicin, remain an important component of several breast cancer chemotherapy regimens. However, their clinical utility is limited by the potential development of anthracycline-induced cardiotoxicity.\n\nDoxorubicin-induced cardiac injury is multifactorial and involves oxidative stress, mitochondrial dysfunction, disturbances in myocardial energy metabolism, apoptosis, inflammation, and progressive myocardial structural damage. Cardiac injury may initially occur without symptoms or an obvious reduction in left ventricular ejection fraction (LVEF). Consequently, identification of early myocardial injury is important because intervention before clinically apparent heart failure may potentially reduce progression to overt cardiac dysfunction.",[103],"Cardiotoxicity",[91,39],"NOT_YET_RECRUITING","2026-09-23",{"date":108,"type":109},"2026-10-01","ACTUAL",{"date":108,"type":97},{"date":112,"type":97},"2028-12-31",{"name":5,"class":6},1]