Huang R; Guangzhou Medical University, China.
Deng Y; Li M; Chen L; Lv M; Liao L; Ma L; Huang Z
Trials [Electronic Resource]. 27(1), 2026 Apr 07.
INTRODUCTION: Heart failure with preserved ejection fraction (HFpEF)
constitutes nearly half of patients with heart failure, but there is still
a lack of treatment options to improve prognosis. Empagliflozin is a new
hypoglycemic medication classified as sodium glucose cotransporter 2
inhibitors (SGLT2i); nonetheless, its effects on exercise tolerance in
HFpEF remain ambiguous. Additional clinical studies are necessary to
clarify the effect of SGLT2i in HFpEF. This study aims to evaluate the
efficacy and safety of empagliflozin on exercise tolerance in patients
with heart failure with preserved ejection fraction without diabetes,
using cardiopulmonary exercise testing.
METHODS AND ANALYSIS: This study is a single-center, open-label,
randomized controlled trial. We will randomly (1:1) assign 86 patients
with an ejection fraction of more than 40% and class II-III heart failure
to receive empagliflozin (10 mg once daily) or to maintain their original
treatment regimen. The treatment duration will be 12 weeks. The primary
endpoint is the evaluation of changes in peak oxygen uptake (peak VO2)
after a 12-week period using cardiopulmonary exercise testing (CPET). The
secondary endpoints encompassed additional parameters of CPET and
echocardiography, N-terminal pro-B-type natriuretic peptide level, alanine
aminotransferase level, aspartate transaminase level, estimated glomerular
filtration rate level, New York Heart Association functional
classification, and scores from the Minnesota Living with Heart Failure
Questionnaire. Safety events associated with empagliflozin and CPET will
be monitored.
DISCUSSION: We used peak oxygen uptake, the gold standard for assessing
exercise tolerance, to evaluate the efficacy and safety of empagliflozin
in treating non-diabetic patients with HFpEF. The improvement in quality
of life of heart failure patients by SGLT2i will be objectively assessed.