Physicians' Academy for Cardiovascular Education

SGLT2i improves health status in HFmrEF/HFpEF

Effect of Dapagliflozin on Health Status in Patients With Preserved or Mildly Reduced Ejection Fraction

Literature - Kosiborod MN, Bhatt AS, Claggett BL, et al. - J Am Coll Cardiol. 2023 Feb 7;81(5):460-473. doi: 10.1016/j.jacc.2022.11.006

Introduction and methods


As patients with HFmrEF or HFpEF experience a high burden of symptoms and physical limitations, and a poor quality of life [1], improving their health status is a crucial goal of patient management. Although several RCTs have shown that SGLT2i treatment can improve health status in this patient population [2-5], there is still uncertainty about the magnitude and consistency of the effects of SGLT2is on health status, especially in HF patients with truly normal LVEF.

Previously, the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial showed that dapagliflozin reduced the risk of CV death or worsening HF events [6]. To examine the effects of dapagliflozin treatment on health status, the authors conducted a prespecified analysis of this trial.

Aim of the study

The study aims were: (1) to evaluate whether the effects of dapagliflozin on clinical outcomes in the DELIVER trial varied according to the degree of symptomatic impairment at baseline; and (2) to examine the effects of dapagliflozin on the broad range of health status outcomes as measured by the various domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ).


In the international, prospective, randomized, double-blind, placebo-controlled DELIVER trial, 6263 patients with symptomatic HFmrEF/HFpEF (NYHA class II–IV HF symptoms, LVEF >40%, elevated NT-proBNP levels) were randomized to dapagliflozin 10 mg or placebo, stratified by T2DM status. For the current analysis, data from 5795 patients with available KCCQ data at baseline were collected. At 1, 4, and 8 months, scores on the following KCCQ domains were evaluated: Total Symptom Score (TSS), Physical Limitations Score (PLS), Clinical Summary Score (CSS), and Overall Summary Score (OSS).


In the DELIVER trial, the primary endpoint was a composite outcome of CV death or worsening HF event (defined as unplanned HF hospitalization or urgent HF visit requiring intravenous therapy). A (prespecified) key secondary endpoint in this trial was the change in KCCQ-TSS from baseline to 8 months.

Main results

Clinical outcomes

Health status outcomes


In a prespecified analysis of the DELIVER trial, dapagliflozin reduced the rate of CV death or worsening HF events to a greater extent in HFmrEF/HFpEF patients with a lower KCCQ-TSS at baseline compared with those with a higher baseline KCCQ-TSS. In addition, dapagliflozin-treated patients showed a larger improvement in all KCCQ domains assessed (symptom burden, physical limitations, and quality of life) at 8 months compared with the placebo group. In the dapagliflozin group, fewer patients had a clinically meaningful deterioration and more experienced a clinically meaningful improvement in the KCCQ-TSS. Finally, baseline LVEF had no effect on the improvement in KCCQ-TSS seen in dapagliflozin-treated patients.


Show references

Find this article online at J Am Coll Cardiol.

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