[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562549":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":92,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Chongqing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine Treatment Group","EXPERIMENTAL","This group is intended to include 100 patients, all of the patients will be given 5mg of once-daily the colchicine treatment on top of the SGLT2i treatment",[13],"Drug: Colchicine 0.5 MG Oral Tablet Once Daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","The group is intended to include 100 patients, all of the patients will be given standard SGLT2i treatment",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Colchicine 0.5 MG Oral Tablet Once Daily","The intervention in this study is colchicine, patients randomized to the experimental group will be given oral colchicine 5mg once a day in 12 weeks.",[9],[26],{"name":27,"affiliation":28,"role":29},"Dongying Zhang, MD. Ph.D.","First Affiliated Hospital of Chongqing Medical University","STUDY_CHAIR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Junlong Chen, MD.","CONTACT","86-15111871817","junlongchen2024@163.com",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Lei Gao, MD.","86-15123908507","653161583@qq.com",[41],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","400000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],106.55771,29.56026,{"lat":52,"lon":51},[55,56,57],{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":32,"role":58,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Dongying Zhang","Director",[64],{"name":65,"class":66},"National Natural Science Foundation of China","OTHER_GOV","100562549","phase-4-colchicine-in-patients-with-heart-failure-with-preserved-ejection-fraction-and-inflammation-100562549",false,"NCT06604611","Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","Efficacy and Safety of Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","CHIPS","Inclusion Criteria:\n\n* Left ventricular ejection fraction measured by echocardiography ≥ 50%\n* Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g\u002Fm2 in female and ≥115 g\u002Fm2 in male or 2)LAVI greater than 29ml\u002Fm2 in sinus rhythm or greater than 40ml\u002Fm2 in atrial fibrillation or 3)Average E\u002Fe' greater than 14 or 4)TR velocity greater than 2.8 m\u002Fs\n* Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg\u002Fml in patients with sinus heart rate; ≥600 pg\u002Fml in patients with atrial fibrillation\n* Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV\n* Patients with CRP levels greater than 2mg\u002FL\n* Patient agrees to join and signs a written informed consent form\n\nExclusion Criteria:\n\n* Received colchicine treatment within one month prior to randomization\n* Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months\n* eGFR less than 25 mL\u002Fmin\u002F1.73 m2\n* Liver function Child-Pugh class B or C\n* Patient has a history of previous allergy to colchicine or dapagliflozin \u002F empagliflozin\n* Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease\n* Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors\n* Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures\n* Pregnant or breastfeeding women\n* The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician\n* Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6\n* Patient with combined active solid tumor or hematological malignancy\n* Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD\n* Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\\*109\u002FL)\n* Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF","ALL","18 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.",[85,86,87,88,89],"Heart Failure","Heart Failure With Preserved Ejection Fraction (HFPEF)","Chronic Inflammation","Inflammation","Colchicine",[85,91,88],"Heart Failure with Preserved Ejection Fraction (HFpEF)","NOT_YET_RECRUITING","2024-09-17",{"date":95,"type":96},"2024-09-19","ACTUAL",{"date":98,"type":79},"2024-10-31",{"date":100,"type":79},"2026-03-31",{"name":61,"class":6},1]