Safety and efficacy of dapagliflozin in patients with systemic right ventricular dysfunction: Preliminary results

Abstract

Introduction

Heart failure (HF) is the leading cause of death in adults with a systemic right ventricle (sRV). Dapagliflozin has been shown to reduce hospitalization for HF and all-cause death in patients with HF and reduced ejection fraction. The impact of dapagliflozin in patients with a sRV remains unknown.

Objective

We aimed to evaluate the efficacy and safety of dapagliflozin in patients with sRV.

Methods

This was a prospective, observational, single-center study. All symptomatic (NYHA ≥ 2) patients with a sRV dysfunction despite optimal medical treatment were included from March 2023 to March 2024. Patients were assessed at baseline and 3, 6 and 12 months after dapagliflozin introduction. The primary endpoint was the 6-minute walk distance. Secondary endpoints included NT-proBNP, quality of life (KCCQ-12), NYHA class, systemic and sub-pulmonary ventricular systolic function, and potential treatment-related side effects.

Expected results

A total of 32 patients were included. Mean age was 48 years (range: 19–79), 20 (62%) of patients were male, 12 (38%) had congenitally corrected transposition of the great arteries and 20 (62%) had transposition of the great arteries with atrial switch. Preliminary results at 6 months were available in 20 patients. There was no statistically significant improvement in 6-minute walk distance (558.0 m vs. 599.5, P = 0.11) nor NT-proBNP (355.5 pg/mL vs. 293.5, P = 0.81). However, the quality of life of patients (80.5 vs. 92.0, P < 0.01) and the right ventricle global longitudinal strain (−11.2% vs. −12.9, P < 0.01) significantly improved. The drug was well tolerated with no side effects reported (Fig. 1).

Perspectives

These preliminary results suggest that dapagliflozin is well tolerated and associated with improved quality of life and right ventricle global longitudinal strain in patients with sRV dysfunction. Final results will bring important data on long-term outcomes associated with dapagliflozin use in this population.