Sodium glucose co-transporter 2 inhibition with empagliflozin on metabolic, cardiac and renal outcomes in recent cardiac transplant recipients (EMPA-HTx): protocol for a randomised controlled trial.

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  • Additional Information
    • Source:
      Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
    • Subject Terms:
      Diabetes Mellitus, Type 2*/complications ; Sodium-Glucose Transporter 2 Inhibitors*/therapeutic use ; Heart Transplantation*; Humans ; Hypoglycemic Agents/therapeutic use ; Sodium-Glucose Transporter 2/therapeutic use ; Prospective Studies ; Benzhydryl Compounds/therapeutic use ; Kidney/physiology ; Glucose/therapeutic use ; Sodium/therapeutic use ; Randomized Controlled Trials as Topic
    • Abstract:
      Introduction: Cardiac transplantation (CTx) is a life-saving operation that can improve the quality and length of a recipient's life. Immunosuppression medication, required to prevent rejection, can result in adverse metabolic and renal effects. Clinically significant complications include metabolic effects such as diabetes and weight gain, renal impairment, and cardiac disease such as allograft vasculopathy and myocardial fibrosis. Sodium glucose co-transporter 2 (SGLT2) inhibitors are a class of oral medication that increase urinary excretion of glucose. In patients with type 2 diabetes, SGLT2 inhibitors improve cardiovascular, metabolic and renal outcomes. Similar benefits have been shown in patients with heart failure and reduced ejection fraction irrespective of diabetes status. In patients with post-transplant diabetes mellitus, SGLT2 inhibitors improve metabolic parameters; however, their benefit and safety have not been evaluated in randomised prospective studies. This study will potentially provide a novel therapy to improve or prevent complications (diabetes, kidney failure and heart fibrosis) that occur with immunosuppressive medications.
      Methods: The EMPA-HTx study is a randomised, placebo-controlled trial of the SGLT2 inhibitor empagliflozin 10 mg daily versus placebo in recent CTx recipients. One hundred participants will be randomised 1:1 and commence the study medication within 6-8 weeks of transplantation with treatment and follow-up until 12 months after transplantation. Demographic information, anthropomorphic measurements, pathology tests and cardiac magnetic resonance (CMR) scan will be recorded at baseline and follow-up. Patients will be reviewed monthly during the study until 12 months post-CTx and data will be collected for each patient at each study visit. The overall aim of the study is to assess the safety and efficacy of empagliflozin in CTx recipients. The primary outcome is glycaemic improvement measured as change in glycated haemoglobin and/or fructosamine. Key secondary outcomes are cardiac interstitial fibrosis measured by CMR and renal function measured by estimated glomerular filtration rate.
      Ethics and Dissemination: This study has been approved by St Vincent's Hospital Human Research Ethics Committee (2021/ETH12184). The findings will be presented at national and international scientific meetings and published in peer-reviewed journals.
      Trial Registration Number: ACTRN12622000978763.
      Competing Interests: Competing interests: None declared.
      (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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    • Contributed Indexing:
      Keywords: CARDIOLOGY; General diabetes; Nephrology; Transplant medicine
    • Accession Number:
      0 (Sodium-Glucose Transporter 2 Inhibitors)
      0 (Hypoglycemic Agents)
      HDC1R2M35U (empagliflozin)
      0 (Sodium-Glucose Transporter 2)
      0 (Benzhydryl Compounds)
      IY9XDZ35W2 (Glucose)
      9NEZ333N27 (Sodium)
    • Publication Date:
      Date Created: 20230329 Date Completed: 20230331 Latest Revision: 20230408
    • Publication Date:
      20240628
    • Accession Number:
      PMC10069602
    • Accession Number:
      10.1136/bmjopen-2022-069641
    • Accession Number:
      36990488