Kidney Week

Abstract: TH-OR049

Effects of Henagliflozin on Cardiac Structure in Patients with Heart Failure with Preserved Ejection Fraction Undergoing Dialysis: The HELD-HF Randomized Controlled Trial

Session Information

• Hemodialysis: Novel Interventions
  November 06, 2025 | Location: Room 351D, Convention Center
  Abstract Time: 05:00 PM - 05:10 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Lu, Renhua, Department of Nephrology, Shanghai Peritoneal Dialysis Research Center, Renji Hospital, Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Renhua Lu, MD

• Gu, Leyi, Department of Nephrology, Shanghai Peritoneal Dialysis Research Center, Renji Hospital, Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Leyi Gu, MD, PhD

Group or Team Name

• HELD-HF Group.

Background

Among patients undergoing dialysis, heart failure with preserved ejection fraction (HFpEF) is frequently observed and associated with increased mortality. This study assessed the safety and efficacy of long-term treatment with henagliflozin, a SGLT2 inhibitor, in improving cardiac structure in dialysis patients with HFpEF.

Methods

In this randomized, double-blind, placebo-controlled trial (ChiCTR2300073169), patients undergoing haemodialysis or peritoneal dialysis with HFpEF (left ventricular ejection fraction ≥50%) were randomized (1:1) to receive henagliflozin 5 mg once daily or matching placebo, in addition to their usual therapy for 24 weeks.The primary outcome was the between-group difference in change in left ventricular mass index (LVMI) from baseline to week 24, as measured by echocardiography. Secondary outcomes were the changes in left atrial volume index (LAVI), E/e’, e’, N-terminal pro-brain natriuretic peptide (NT-proBNP) after 24 weeks of treatment. Adverse events were recorded until 28 weeks after enrollment. Efficacy analyses were conducted according to the full analysis set.

Results

From September 2023 to February 2024, 112 patients were randomized. From baseline to week 24, the mean change in LVMI was –3.38 ± 12.00 g/m² in the henagliflozin group and 2.08 ± 12.25 g/m² in the placebo group, with a between-group difference of -5.38 g/m² (95%CI, -10.12 to -0.64 g/m²; p=0.026) (table 1). Sensitivity analysis using last observation carried forward imputation and per protocol populations showed similar results, supporting a significant reduction in LVMI with henagliflozin versus placebo. No differences were observed between the two groups in secondary efficacy outcomes, including LAVI, E/e’, e’, and NT-proBNP. The incidence of adverse events was similar between the two groups (35.7% in the henagliflozin group and 32.1% in the placebo group).

Conclusion

Henagliflozin significantly reduced LVMI compared with placebo in patients with HFpEF on dialysis and was safe over 24 weeks of treatment.

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025yem71v7w