A Study of Metformin to Improve Cardiac Function After LVAD Implantation

Korábbi kezelés

• Receiving any form of renal replacement therapy (hemodialysis, peritoneal dialysis)
• Post-kidney transplantation or awaiting kidney transplantation
• Concurrent right ventricular assist device (RVAD) or total artificial heart implantation
• Acute kidney injury requiring ongoing renal replacement therapy (CRRT) within 30 days postoperatively
• 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
• Prior recipients of heart transplantation or other organ transplants
• 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)
• 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/day for > 2 weeks), high-dose thiazide diuretics (hydrochlorothiazide > 50 mg/day), atypical antipsychotics (olanzapine, clozapine, etc.), immunosuppressants (tacrolimus, cyclosporine, etc.)
• Concurrent participation in another clinical trial

Más betegség

• History of diagnosed diabetic ketoacidosis or hyperosmolar hyperglycemic state
• History of diagnosed polycystic ovary syndrome (PCOS) and currently undergoing treatment
• History of acute kidney injury (KDIGO criteria) with incomplete renal recovery
• Active viral hepatitis
• History of alcoholic liver disease or drug-induced liver injury currently in the active phase
• 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
• Preoperative severe right heart failure (on echocardiography: right ventricular fractional area change < 35%, or tricuspid annular plane systolic excursion < 14 mm; or right heart catheterization showing central venous pressure > 15 mmHg and cardiac index < 2.0 L/min/m²)
• Preoperative severe pulmonary arterial hypertension (mean pulmonary arterial pressure ≥ 40 mmHg and pulmonary vascular resistance ≥ 4 Wood units)
• Within 30 days postoperatively, occurrence of severe low cardiac output syndrome requiring extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support
• Severe unrepaired valvular disease
• Active systemic infection or sepsis requiring ongoing intravenous antibiotics or antifungal therapy
• Active tuberculosis or non-tuberculous mycobacterial infection
• Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection
• Known active inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) currently requiring immunosuppressive therapy
• Known bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired von Willebrand syndrome)
• Patients awaiting heart transplantation with an anticipated waiting time of less than 3 months
• Known allergy to metformin or any drug excipient
• Known history of lactic acidosis
• Known psychiatric disorders or cognitive impairment that may affect informed consent validity or study compliance
• History of drug or alcohol abuse (within the past year)

Laborértékek

• 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)
• Currently using any glucose-lowering medications (including insulin, oral hypoglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, etc.)
• Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² (CKD-EPI equation)
• 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
• Human immunodeficiency virus (HIV) infection with CD4 count < 200/μL or not on regular antiretroviral therapy
• Platelet count < 50 × 10⁹/L, hemoglobin < 80 g/L, international normalized ratio (INR) > 3.0 and not reversible (unless on warfarin with INR within the target range)

Életkor

• 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.)

Egyéb

• Significant prosthetic valve dysfunction or severe prosthetic valve infectious endocarditis
• Active infectious endocarditis (modified Duke criteria) or high clinical suspicion
• Pregnant or lactating women
• Women planning pregnancy during the study
• Unable to complete 12-month follow-up
• 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)

• Age 18-75 years
• Receiving continuous-flow LVADs, such as HeartMate 3, HVAD, Core-Heart 6, Brio-Heart
• Presence of insulin resistance
• HbA1c ≤ 6.5%