[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644191":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin Group","EXPERIMENTAL","Metformin hydrochloride tablets administered orally with a dose-escalation schedule to reduce gastrointestinal adverse effects and risk of lactic acidosis. The titration schedule is as follows: Weeks 1-2: 250 mg once daily (after dinner); Weeks 3-4: 500 mg once daily (after dinner); Weeks 5-6: 750 mg total daily (500 mg after dinner + 250 mg after breakfast); Weeks 7-8: 1000 mg total daily (500 mg after dinner + 500 mg after breakfast) - target dose; Weeks 9-10: 1250 mg total daily (500 mg after dinner + 750 mg after breakfast) - optional target dose. The maintenance period extends from Week 10 to Week 52, during which patients maintain the target dose or maximum tolerated dose (must be ≥750 mg per day). Dose adjustment or temporary withholding may be considered based on tolerability and renal function (eGFR).",[13],"Drug: Metformin Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Matching placebo tablets, identical in appearance to metformin, administered orally following the same dose-escalation schedule as the metformin group (based on tablet count), from Week 1 through Week 52.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin Hydrochloride","Metformin hydrochloride tablets, 250 mg and 500 mg, administered orally with a dose-escalation schedule over 10 weeks to achieve target dose, followed by a maintenance period from Week 10 to Week 52. Dose adjustments based on tolerability and renal function.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo tablets, identical in appearance to metformin, administered orally following the same dose-escalation and maintenance schedule as the active comparator.",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":26},"Dong-Jin Wang","Nanjing","Jiangsu","210008","China","CN",{"type":40,"coordinates":41},"Point",[42,43],118.77778,32.06167,{"lat":43,"lon":42},{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100644191","phase-1-a-study-of-metformin-to-improve-cardiac-function-after-lvad-implantation-100644191",false,"NCT07666698","A Study of Metformin to Improve Cardiac Function After LVAD Implantation","Study on the Effect of Metformin in Improving Cardiac Function After Implantation of Left Ventricular Assist Devices","Inclusion Criteria:\n\n* Age 18-75 years\n* Receiving continuous-flow LVADs, such as HeartMate 3, HVAD, Core-Heart 6, Brio-Heart\n* Presence of insulin resistance\n* HbA1c ≤ 6.5%\n\nExclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus, or type 2 diabetes mellitus with HbA1c \\> 6.5% (patients with prior type 2 diabetes who are currently off therapy and have HbA1c ≤ 6.5% may be enrolled; such patients may still have insulin resistance but have achieved glycemic control)\n* History of diagnosed diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Currently using any glucose-lowering medications (including insulin, oral hypoglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, etc.)\n* History of diagnosed polycystic ovary syndrome (PCOS) and currently undergoing treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation)\n* History of acute kidney injury (KDIGO criteria) with incomplete renal recovery\n* Receiving any form of renal replacement therapy (hemodialysis, peritoneal dialysis)\n* Post-kidney transplantation or awaiting kidney transplantation\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3× the upper limit of normal, total bilirubin \\> 2× upper limit of normal, or Child-Pugh class B or C cirrhosis\n* Active viral hepatitis\n* History of alcoholic liver disease or drug-induced liver injury currently in the active phase\n* Concurrent right ventricular assist device (RVAD) or total artificial heart implantation\n* LVAD-related complications requiring surgical intervention within 30 days postoperatively, including but not limited to: pump thrombosis requiring LVAD exchange or thrombolysis, driveline infection requiring debridement or replacement, hemorrhagic complications requiring re-sternotomy, device malfunction requiring urgent intervention\n* Acute kidney injury requiring ongoing renal replacement therapy (CRRT) within 30 days postoperatively\n* Preoperative severe right heart failure (on echocardiography: right ventricular fractional area change \\\u003C 35%, or tricuspid annular plane systolic excursion \\\u003C 14 mm; or right heart catheterization showing central venous pressure \\> 15 mmHg and cardiac index \\\u003C 2.0 L\u002Fmin\u002Fm²)\n* Preoperative severe pulmonary arterial hypertension (mean pulmonary arterial pressure ≥ 40 mmHg and pulmonary vascular resistance ≥ 4 Wood units)\n* Within 30 days postoperatively, occurrence of severe low cardiac output syndrome requiring extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support\n* Significant prosthetic valve dysfunction or severe prosthetic valve infectious endocarditis\n* Severe unrepaired valvular disease\n* Active systemic infection or sepsis requiring ongoing intravenous antibiotics or antifungal therapy\n* Active infectious endocarditis (modified Duke criteria) or high clinical suspicion\n* Human immunodeficiency virus (HIV) infection with CD4 count \\\u003C 200\u002FμL or not on regular antiretroviral therapy\n* Active tuberculosis or non-tuberculous mycobacterial infection\n* Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection\n* Known active inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) currently requiring immunosuppressive therapy\n* Platelet count \\\u003C 50 × 10⁹\u002FL, hemoglobin \\\u003C 80 g\u002FL, international normalized ratio (INR) \\> 3.0 and not reversible (unless on warfarin with INR within the target range)\n* Known bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired von Willebrand syndrome)\n* Malignancy diagnosed within the past 5 years (except for cured thyroid cancer, breast cancer, lung cancer, cervical cancer, etc.) and currently receiving chemotherapy, radiotherapy, or targeted therapy\n* Prior recipients of heart transplantation or other organ transplants\n* Patients awaiting heart transplantation with an anticipated waiting time of less than 3 months\n* Pregnant or lactating women\n* Reproductive-age women who are capable of conceiving but refuse to use effective contraception during the study period (including surgical sterilization, intrauterine device, oral contraceptives, condoms, etc.)\n* Women planning pregnancy during the study\n* Known allergy to metformin or any drug excipient\n* Known history of lactic acidosis\n* Currently using medications that may significantly increase the risk of lactic acidosis, including but not limited to: carbonic anhydrase inhibitors (topiramate, acetazolamide), antiretroviral drugs (especially nucleoside reverse transcriptase inhibitors), certain chemotherapeutic agents (cisplatin)\n* Currently using medications that may affect glycemic control or insulin sensitivity and that cannot be stopped or substituted during the study, including but not limited to: systemic glucocorticoids (prednisone-equivalent dose \\> 10 mg\u002Fday for \\> 2 weeks), high-dose thiazide diuretics (hydrochlorothiazide \\> 50 mg\u002Fday), atypical antipsychotics (olanzapine, clozapine, etc.), immunosuppressants (tacrolimus, cyclosporine, etc.)\n* Unable to complete 12-month follow-up\n* Known psychiatric disorders or cognitive impairment that may affect informed consent validity or study compliance\n* History of drug or alcohol abuse (within the past year)\n* Concurrent participation in another clinical trial\n* Any other circumstance, as determined by the investigator, that would render the subject unsuitable for enrollment (including but not limited to social, psychological, or geographic factors)","ALL","18 Years","75 Years",{"count":58,"type":59},108,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","This study investigates whether metformin, compared with placebo, improves cardiac function in patients after Left Ventricular Assist Device (LVAD) implantation. Metformin is a widely used oral medication for type 2 diabetes, but emerging evidence suggests it may have beneficial effects on cardiac metabolism and function independent of its glucose-lowering effects. This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 108patients undergoing LVAD implantation will be enrolled from 5 centers in China. Eligible participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for 12 months.\n\nThe primary outcome is the incidence of Full Responder at 12 months post-implantation. A Full Responder is defined as meeting all of the following four criteria: (1) left ventricular ejection fraction (LVEF) ≥40% and left ventricular end-diastolic diameter (LVEDD) ≤6.0 cm (Utah-Inova Responder criteria); (2) soluble ST2 (sST2) ≤100 ng\u002FmL at both 6 months and 12 months post-implantation; (3) absolute value of left ventricular global longitudinal strain (GLS) ≥12% at 12 months post-implantation.\n\nSecondary outcomes include clinical events, cardiac function status, blood biomarker results, global functional status and quality of life, medication safety, and exploratory measures. Clinical events assessed up to 24 months post-implantation include: heart failure rehospitalization rate, all-cause mortality, LVAD explantation rate, cardiovascular mortality, major bleeding, cardiac structural damage, thromboembolic events, systemic inflammatory dissemination, sepsis, and other serious adverse events.\n\nCardiac function status is evaluated by echocardiographic parameters (LVEF, LVEDD, GLS) and hemodynamic measures. Blood biomarkers include sST2, NT-proBNP, cardiac troponin, and inflammatory cytokines. Global functional status and quality of life are measured using the 6-minute walk test (6MWT), peak oxygen consumption (VO₂max), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Safety outcomes include the incidence and severity of adverse events, serious adverse events, and adverse events of special interest. Exploratory outcomes include pre-implantation right ventricular myocardial biopsy (obtained only when clinically indicated for temporary pacemaker lead placement) to assess insulin receptor substrate (IRS)\u002FAkt phosphorylation, G6PD activity, NADPH\u002FNADP⁺ ratio, and oxidative stress markers (malondialdehyde, 4-hydroxynonenal).\n\nThe study aims to provide evidence on whether adjunctive metformin therapy can improve post-LVAD cardiac outcomes and reduce adverse clinical events.",[66,67],"Heart Failure","Left Ventricular Assist Device",[69,70,71,72,73],"Metformin","Cardiac Function","LVAD","Randomized Controlled Trial","Full Responder","NOT_YET_RECRUITING","2026-06-18",{"date":77,"type":78},"2026-06-24","ACTUAL",{"date":80,"type":59},"2026-07",{"date":82,"type":59},"2029-09",{"name":5,"class":6},1]