Could a common diabetes drug boost heart pump recovery?
NCT ID NCT07666698
First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study tests whether metformin, a standard diabetes medicine, can improve heart function in people who have received a mechanical heart pump (LVAD) for severe heart failure. Researchers will give metformin or a placebo to 108 patients for 12 months and check heart function, blood markers, and overall health. The goal is to see if metformin helps the heart recover better and reduces complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (a diabetes drug)
- What this could lead to
- If it works, metformin could become a simple, cheap add-on therapy to help heart recovery after LVAD implantation, reducing complications and improving quality of life.
- What could go wrong
- This is an early-phase (1/2) trial with only 108 people, so results may not apply broadly. Metformin is generally safe but can cause gastrointestinal side effects; it may also not improve heart function as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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% Exclusion Criteria: * 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) * History of diagnosed diabetic ketoacidosis or hyperosmolar hyperglycemic state * Currently using any glucose-lowering medications (including insulin, oral hypoglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, etc.) * History of diagnosed polycystic ovary syndrome (PCOS) and currently undergoing treatment * Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m² (CKD-EPI equation) * History of acute kidney injury (KDIGO criteria) with incomplete renal recovery * Receiving any form of renal replacement therapy (hemodialysis, peritoneal dialysis) * Post-kidney transplantation or awaiting kidney transplantation * 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 * Active viral hepatitis * History of alcoholic liver disease or drug-induced liver injury currently in the active phase * Concurrent right ventricular assist device (RVAD) or total artificial heart implantation * 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 * Acute kidney injury requiring ongoing renal replacement therapy (CRRT) within 30 days postoperatively * 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 * Significant prosthetic valve dysfunction or severe prosthetic valve infectious endocarditis * Severe unrepaired valvular disease * Active systemic infection or sepsis requiring ongoing intravenous antibiotics or antifungal therapy * Active infectious endocarditis (modified Duke criteria) or high clinical suspicion * Human immunodeficiency virus (HIV) infection with CD4 count \< 200/μL or not on regular antiretroviral 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 * 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) * Known bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired von Willebrand syndrome) * 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 * Patients awaiting heart transplantation with an anticipated waiting time of less than 3 months * Pregnant or lactating women * 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.) * Women planning pregnancy during the study * Known allergy to metformin or any drug excipient * Known history of lactic acidosis * 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.) * Unable to complete 12-month follow-up * 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) * Concurrent participation in another clinical trial * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Provincial Chest Hospital, Chest Hospital of Zhengzhou University
RECRUITINGZhengzhou, 450000, China
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Huai'an Hospital Affiliated to Yangzhou University
RECRUITINGHuai'an, 223300, China
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Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing University
RECRUITINGNanjing, Jiangsu, 210008, China
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The First Affiliated Hospital of Harbin Medical University
RECRUITINGHa’erbin, 150001, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310003, China
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