Safety and efficacy of SGLT2i administration in dilated cardiomyopathy: protocol for a systematic review and meta-analysis.

Abstract

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.

Trial registration: PROSPERO CRD42023417892.