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STUDY PROTOCOL article

Front. Cardiovasc. Med.

Sec. Heart Failure and Transplantation

Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1575493

Safety and Efficacy of SGLT2i Administration in Dilated Cardiomyopathy: Protocol for A Systematic Review and Meta-Analysis

Provisionally accepted
  • West China Second University Hospital, Sichuan University, Chengdu, China

The final, formatted version of the article will be published soon.

Background: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have emerged as a promising treatment for heart failure and cardiomyopathy. Furthermore, recent research has explored the use of SGLT2i in patients with dilated cardiomyopathy (DCM). However, the evidence that SGLT2i can improve left ventricular function and reduce symptoms of heart failure in DCM patients is limited. Objective: The objective of our study was to assess the efficacy and safety of SGLT2i in managing DCM patients with heart failure and to predict its effectiveness in DCM patients without heart failure. The benefits of SGLT2i alone or in combination will also be determined. Methods: A structured search of bibliographic databases (PubMed, Embase, and the Cochrane Central Register of Controlled Trials) will be undertaken to retrieve randomized controlled trials and cohorts that describe the efficacy and safety of SGLT2i as a major therapy strategy for DCM patients. To ensure that all relevant data were captured, the search did not contain any restrictions on language or publication time. Primary efficacy outcomes will be all-causes mortality and cardiovascular mortality. Primary safety outcomes will be the incidence of hypoglycemia, liver and renal injuries, and recurrent respiratory tract infections. After deduplication, citations will be screened independently by 2 authors, and selected for inclusion based on prespecified criteria. Data extraction and risk of bias assessment will be performed independently and in duplicate. Conclusions: This study could potentially provide new insights into the therapeutic strategies for dilated cardiomyopathy patients and reforming clinical guidelines for using SGLT2i to ensure patient safety and medicine efficacy.

Keywords: SGLT2I, dilated cardiomyopathy, efficacy, outcomes, Meta-analysis

Received: 25 Mar 2025; Accepted: 28 Aug 2025.

Copyright: © 2025 Li, Hu, Yu, Li and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Yifei Li, West China Second University Hospital, Sichuan University, Chengdu, China

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