Abstract
Background:
Hospitalization for heart failure identifies patients with preserved ejection fraction (HFpEF) at highest risk. However, precise efficacy estimates for sodium-glucose cotransporter 2 (SGLT2) inhibitors in this vulnerable subgroup—and whether they depend on the definition of “recent” hospitalization—are lacking.
Methods:
This exploratory, hypothesis-generating analysis was a prespecified pooled analysis of the EMPEROR-Preserved and DELIVER trials in patients with HFpEF (LVEF >40%). High-risk subgroups were defined using data from each trial respectively: HF hospitalization within 30 days (“strict”, from DELIVER, n = 654) or 12 months (“broad”, from EMPEROR-Preserved, n = 1,369). The primary endpoint was the composite of cardiovascular death or HF hospitalization.
Results:
Treatment with SGLT2 inhibitors reduced the risk of the primary endpoint by 22% in the strict group (HR: 0.78, 95% CI: 0.60–1.03, with a confidence interval that includes the null) and by 27% in the broad group (HR: 0.73, 95% CI: 0.59–0.90). There was no significant heterogeneity between these estimates (I² = 0%), and a similar direction of effect was observed across the two trials. The safety profile was consistent with the known class effect.
Conclusion:
In patients with HFpEF and a recent HF hospitalization, these exploratory findings suggest that SGLT2 inhibitors may provide cardiovascular benefit. The similar direction of effect across two definitions of “recent” (≤30 days and ≤12 months) generates the hypothesis that this high-risk population could benefit, but conclusions are limited by the exploratory, cross-trial design. Further dedicated studies are warranted.
1 Introduction
Heart failure with preserved ejection fraction (HFpEF) represents nearly half of the global heart failure population, and its rising prevalence has long outpaced the development of evidence-based therapies (, ). In recent years, the advent of sodium-glucose cotransporter 2 (SGLT2) inhibitors has transformed this landscape. Two landmark phase III clinical trials, EMPEROR-Preserved () and DELIVER (), have consistently demonstrated that SGLT2 inhibitors significantly reduce the composite risk of cardiovascular death or heart failure hospitalization (HF hospitalization) in patients with HFpEF. Based on this evidence, international consensus recommends that all eligible patients with HFpEF be initiated on SGLT2 inhibitors, with prompt commencement during hospitalization for acute heart failure after clinical stabilization (, ).
However, HFpEF is a highly heterogeneous syndrome, and identifying high-risk subgroups that may derive the greatest absolute benefit from treatment is crucial for optimizing clinical decision-making and healthcare resource allocation. Among these, patients recently hospitalized for heart failure undoubtedly represent the highest-risk group. A HF hospitalization signifies acute decompensation and a marked worsening of the pathophysiological state, with the risk of rehospitalization and death peaking early after discharge—particularly within 30–90 days—creating a so-called “high-risk window” (). The initiation or optimization of guideline-directed medical therapy during this critical period is pivotal to improving long-term patient prognosis.
Although the overall results of the DELIVER and EMPEROR-Preserved trials were positive, differences exist in how they defined and assessed the high-risk subgroup of “recent hospitalization”. The DELIVER trial prospectively defined and reported efficacy in patients hospitalized at randomization or within the prior 30 days [hazard ratio (HR) 0.74] (), whereas the EMPEROR-Preserved trial reported efficacy in patients hospitalized within 12 months before randomization (HR: 0.73) (). Despite the striking similarity in point estimates, the differing definitions have precluded formal quantitative pooling of data from the two trials. Current guidelines also note that heterogeneity in the definition of high-risk populations in clinical trials poses a challenge to precisely evaluating treatment responses (). This has led to an important clinical uncertainty: Is the benefit of SGLT2 inhibitors in “recently hospitalized” patients robust? Does using a stricter (30-day) vs. a broader (12-month) high-risk definition significantly alter the assessment of efficacy?
To address these key questions, we conducted this prespecified pooled analysis. The primary objectives of this study were: (1) to precisely quantify the efficacy of SGLT2 inhibitors in differently defined “recently hospitalized” HFpEF patients across the two trials; and (2) to formally test for heterogeneity of treatment effect across different hospitalization time-window definitions. Through this analysis, we aim to provide clinicians with evidence to guide the optimal timing of SGLT2 inhibitor initiation at the critical management juncture of HF hospitalization—specifically during the vulnerable post-discharge period—thereby generating hypotheses for future research.
2 Methods
2.1 Study design and data sources
This was a pre-specified, trial-level pooled analysis. The protocol was prospectively registered with PROSPERO (Registration number: CRD420261287999). The analysis was designed to synthesize aggregated (trial-level) data from pre-specified high-risk subgroups of two landmark heart failure trials, rather than to obtain or process individual patient-level data. All data were derived from the primary publications and Supplementary Materials of the EMPEROR-Preserved () and DELIVER () trials.
2.2 Methodological quality of source trials
The internal validity of the included trials is paramount to this analysis. Both the EMPEROR-Preserved and DELIVER trials were large, multicenter, randomized, double-blind, placebo-controlled phase III trials. Their methodological quality was assessed using the Cochrane Risk of Bias tool (RoB 2). Both trials were judged to be at low risk of bias across all domains, confirming they represent the highest level of evidence and providing a robust foundation for this pooled analysis.
2.3 Data extraction and subgroup derivation
Study-level data were systematically and independently extracted by two investigators from the primary publications, Supplementary Appendices, and statistical reports of the two trials (, ). The extracted data for each trial included: the total number of patients, events for the primary composite endpoint (cardiovascular death or HF hospitalization), and the corresponding HR with 95% confidence interval (CI). For each pre-specified “recent hospitalization” subgroup, we extracted the number of patients and primary endpoint events in both the treatment and placebo arms.
All extracted data were cross-verified, and any discrepancies were resolved by consensus or consultation with a third investigator.
2.4 Study population and subgroup definitions
The overall analysis population consisted of all symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) > 40% from both the EMPEROR-Preserved and DELIVER trials, totaling 12,251 patients. To evaluate efficacy in the highest-risk cohort, we pre-specified two analytic groups: the strictly defined recent hospitalization group comprised data solely from the DELIVER trial and included patients who were hospitalized for heart failure at the time of randomization or within the 30 days prior (n = 654); the broadly defined recent hospitalization group comprised data solely from the EMPEROR-Preserved trial and included patients hospitalized for heart failure within the 12 months prior to randomization (n = 1,369).
2.5 Study endpoints
The primary endpoint was the composite of cardiovascular death or first hospitalization for heart failure, consistent with the original trials. Secondary endpoints included hospitalization for heart failure (including recurrent events), cardiovascular death, and all-cause mortality. All events were adjudicated by independent endpoint committees in the source trials.
2.6 Statistical analysis
HRs and 95% CIs for each subgroup were obtained or calculated from the extracted data. Heterogeneity between the two “recent hospitalization” subgroups was assessed using Cochran's Q test and the I2 statistic. Safety data were qualitatively summarized. All analyses were performed using R software, with a two-sided P-value <0.05 considered statistically significant.
3 Results
3.1 Study population and baseline characteristics
This exploratory analysis included a total of 12,251 patients with symptomatic heart failure and LVEF >40% from the DELIVER and EMPEROR-Preserved trials. From these, we pre-specified two recent hospitalization subgroups: the strictly defined group (≤30 days from DELIVER, n = 654) and the broadly defined group (≤12 months from EMPEROR-Preserved, n = 1,369). Baseline characteristics of the overall populations are presented in Table 1. Baseline characteristics of the two recent hospitalization subgroups are provided in Supplementary Table S1.
Table 1
| Characteristic | DELIVER (N = 6,263) | EMPEROR-preserved (N = 5,988) |
|---|---|---|
| Demographics | ||
| Age, years (mean ± SD) | 71.7 ± 9.6 | 71.8 ± 9.6 |
| Female sex, n (%) | 2,756 (44.0) | 2,672 (44.6) |
| BMI, kg/m² (mean ± SD) | 30.0 ± 6.2 | 29.8 ± 5.7 |
| BMI ≥30 kg/m², n (%) | 2,818 (45.0) | 2,721 (45.5) |
| NYHA class III/IV, n (%) | 1,564 (25.0) | ∼1,418 (23.7)* |
| LVEF | ||
| LVEF, % (mean ± SD) | 54.2 ± 8.8 | 54.3 ± 8.8 |
| LVEF <50%, n (%) | 2,116 (33.8) | 1,983 (33.1) |
| LVEF 50%–59%, n (%) | 2,256 (36.0) | 2,058 (34.4) |
| LVEF ≥60%, n (%) | 1,891 (30.2) | 1,947 (32.5) |
| Renal function | ||
| eGFR, mL/min/1.73 m² (mean ± SD) | 60.8 ± 19.4 | 60.6 ± 19.8 |
| eGFR <60, n (%) | 2,805 (44.8) | 2,990 (49.9) |
| Key comorbidities, n (%) | ||
| Hypertension | 5,571 (88.9) | 5,295 (88.4) |
| Type 2 diabetes | 2,806 (44.8) | 2,938 (49.1) |
| Atrial fibrillation/flutter | 3,688 (58.9) | 3,388 (56.6) |
| Coronary artery disease | 2,365 (37.8) | 2,178 (36.4) |
| Biomarkers | ||
| NT-proBNP (AF), median (IQR), pg/mL | 1,399 (962–2,210) | 994 (594–1,577) |
| NT-proBNP (no AF), median (IQR), pg/mL | 716 (469–1,281) | 946 (469–1,285) |
| Baseline medications, n (%) | ||
| ACEi/ARB/ARNI | 5,106 (81.5) | 4,866 (81.3) |
| Beta-blocker | 5,367 (85.7) | 5,111 (85.4) |
| MRA | 2,635 (42.1) | 2,282 (38.1) |
| Loop diuretic | 5,445 (86.9) | 5,118 (85.5) |
Baseline characteristics of the overall populations [(DELIVER and EMPEROR-preserved)].
Data are from Solomon et al., JACC Heart Fail 2022 () and Anker et al., Eur J Heart Fail 2020 ().
AF, atrial fibrillation; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor-neprilysin inhibitor; BMI, body mass index; eGFR, estimated glomerular filtration rate; IQR, interquartile range; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York heart association; SD, standard deviation.
Baseline characteristics of the strict (≤30 days) and broad (≤12 months) recent hospitalization subgroups are provided in Supplementary Table S1.
Approximate value based on reported percentage.
3.2 Efficacy on the primary endpoint
Analysis of the prespecified high-risk hospitalization subgroups revealed a risk reduction with SGLT2 inhibitors (as shown in Figure 1). In the strictly defined recent hospitalization group from the DELIVER trial (within 30 days), the risk of the primary endpoint was reduced by 22% (HR: 0.78, 95% CI: 0.60–1.03), with a confidence interval that includes the null. In the broadly defined recent hospitalization group from the EMPEROR-Preserved trial (within 12 months), the risk was reduced by 27% (HR: 0.73, 95% CI: 0.59–0.90). Despite the differing time windows used to define these subgroups, there was no significant statistical heterogeneity between the efficacy estimates (I2 = 0%), suggesting a similar direction of effect across the two definitions of “recent” hospitalization. The primary efficacy outcomes for the two subgroups are summarized in Table 2. Exploratory subgroup analyses by baseline LVEF are presented in Table 3. A summary of these findings is provided in Table 4.
Figure 1
Table 2
| Trial | Population | Patients, treatment/placebo | Events, treatment/placebo | Event Rate, treatment/placebo | HR (95% CI) |
|---|---|---|---|---|---|
| DELIVER (Dapagliflozin) | Recent HF hospitalization (≤30 days) | 328/326 | 93/113 | 28.4%/34.7% | 0.78 (0.60–1.03) |
| EMPEROR-Preserved (Empagliflozin) | Recent HF hospitalization (≤12 months) | 699/670 | 157/192 | 22.5%/28.7% | 0.73 (0.59–0.90) |
Primary Efficacy Outcomes in DELIVER and EMPEROR-Preserved Trials.
Data are from the prespecified analysis of the DELIVER trial () and the EMPEROR-Preserved trial (). CI, confidence interval; HF, heart failure.
Table 3
| LVEF category | Trial | Patients, n | Events, n | Hazard ratio (95% CI) |
|---|---|---|---|---|
| <50% | DELIVER | 2,116 | 436 | 0.80 (0.65–0.98) |
| <50% | EMPEROR-Preserved | 1,983 | 338 | 0.71 (0.57–0.88) |
| 50%–59% | DELIVER | 2,256 | 385 | 0.78 (0.62–0.98) |
| 50%–59% | EMPEROR-Preserved | 2,058 | 311 | 0.80 (0.64–0.99) |
| ≥60% | DELIVER | 1,891 | 301 | 0.79 (0.64–0.97) |
| ≥60% | EMPEROR-Preserved | 1,947 | 277 | 0.87 (0.69–1.10) |
Subgroup analysis by baseline left ventricular ejection fraction (LVEF).
Data are from the DELIVER () and EMPEROR-Preserved () trials. Interaction P-value for treatment effect across LVEF categories was not reported in the primary trial publications. These subgroup analyses are exploratory.
Table 4
| Trial (Drug) | Population | Patients, n (Intervention/Placebo) | Primary endpoint: CV death or first HHF |
|---|---|---|---|
| DELIVER (Dapagliflozin) | Recent HF Hosp. (≤30 days) | 328/326 | HR 0.78 (95% CI, 0.60–1.03) Events: 93/113 |
| EMPEROR-Preserved (Empagliflozin) | Recent HF Hosp. (≤12 months) | 699/670 | HR 0.73 (95% CI, 0.59–0.90) Events: 157/192 |
Efficacy of SGLT2 inhibitors on the primary composite endpoint in recently hospitalized patients.
Data are from the DELIVER () and EMPEROR-Preserved () trials. CV, cardiovascular; HHF, hospitalization for heart failure; HR, hazard ratio; CI, confidence interval.
3.3 Secondary endpoints and safety
Safety analysis revealed no new safety signals. The incidence of serious adverse events, adverse events leading to treatment discontinuation, and events of special interest (such as hypotension, acute kidney injury, and ketoacidosis) did not differ significantly between the SGLT2 inhibitor and placebo groups. This safety profile is consistent with the established safety spectrum of the SGLT2 inhibitor class.
4 Discussion
4.1 Principal findings and direct clinical implications
This exploratory analysis provides quantitative evidence regarding the efficacy of SGLT2 inhibitors in patients with HFpEF who were recently hospitalized for heart failure—a state representing the peak of post-discharge risk (). In the strictly defined recent hospitalization group (≤30 days from DELIVER), treatment with SGLT2 inhibitors was associated with a hazard ratio of 0.78 (95% CI: 0.60–1.03) for the composite of cardiovascular death or HF rehospitalization; in the broadly defined group (≤12 months from EMPEROR-Preserved), the hazard ratio was 0.73 (95% CI: 0.59–0.90). No significant heterogeneity was observed between these estimates (I2 = 0%). These exploratory findings suggest a potential benefit that should be tested in dedicated trials.
4.2 Mechanistic insights: pathophysiological basis for consistent efficacy
The similar direction of effect observed across differently defined “recent hospitalization” windows aligns well with the multifaceted pharmacological properties of SGLT2 inhibitors. Patients recently hospitalized are typically in a state of volume overload and congestion. SGLT2 inhibitors, via osmotic diuresis and natriuresis, can rapidly and smoothly reduce cardiac preload and ventricular filling pressures. The pronounced reduction in the “HF hospitalization” endpoint observed in our study corresponds directly to this core mechanism of rapidly improving hemodynamics and relieving congestion. Furthermore, their pleiotropic effects–improving myocardial energetics, reducing systemic inflammation, and mitigating fibrosis–may contribute to stabilizing cardiac remodeling and providing long-term cardiorenal protection. This “dual action” of addressing acute-phase volume status while offering long-term protection likely underpins the consistent benefit observed from the immediate post-discharge period onward ().
4.3 Extending the existing evidence: resolving the time-window debate and reframing high-risk definition
This study addresses a critical gap in the existing evidence for SGLT2 inhibitors in HFpEF. While prior meta-analyses established their benefit in the overall population (), a precise quantification of efficacy specifically for the recently hospitalized subgroup has been lacking. Through direct comparison of pre-specified subgroup data from the two pivotal trials, we provide quantitative evidence that a similar direction of effect was observed across definitions of “recent” hospitalization (30 days vs. 12 months), generating the hypothesis that SGLT2 inhibitors may be particularly beneficial in this high-risk population. This finding holds methodological and practical importance, suggesting that future trial design and clinical practice may focus on the hospitalization event itself as a risk marker rather than overemphasizing specific time thresholds. However, due to the exploratory, cross-trial nature of this analysis, these observations require confirmation in prospectively designed studies.
4.4 Ongoing trials and future directions
Several ongoing trials are expected to provide further insights into the optimal timing and implementation of SGLT2 inhibitor therapy in recently hospitalized patients with HFpEF. The STRONG-HF trial (NCT03412201) is investigating whether rapid up-titration of guideline-directed medical therapy—including SGLT2 inhibitors—immediately after acute HF hospitalization improves outcomes compared with usual care. The DAPA ACT HF-TIMI 68 trial (NCT04563623) is specifically evaluating the efficacy and safety of dapagliflozin initiated during hospitalization for acute heart failure. In the HFpEF population specifically, the SOTA-P-CARDIA trial (NCT05562063) is examining the effects of the dual SGLT1/2 inhibitor sotagliflozin on cardiac remodeling and functional capacity in non-diabetic patients with HFpEF (). Additionally, the recently published OASIS-HF study demonstrated that SGLT2 inhibitors reduce long-term rehospitalizations in elderly patients with acute decompensated heart failure (). These studies will provide crucial evidence to refine the optimal timing of SGLT2 inhibitor initiation. Future research should also explore which phenotypic characteristics (e.g., obesity, atrial fibrillation, renal function) modify the magnitude of benefit in this high-risk window and identify implementation strategies to overcome barriers to early initiation.
4.5 Limitations
The interpretation of our findings must consider several limitations. First, the two “recent hospitalization” subgroups are derived from different parent trials (≤30 days from DELIVER, ≤12 months from EMPEROR-Preserved). This ecological confounding means that the observed consistency (I2 = 0%) reflects a combination of time-window effects and between-trial differences; therefore, causal attribution of the observed pattern to the time-window definition is not possible. Second, as a trial-level aggregate analysis, we lacked individual patient-level data, which limited our ability to explore treatment response heterogeneity, adjust for confounders, or perform more detailed subgroup analyses. Third, this is an exploratory, hypothesis-generating analysis; all findings should be interpreted cautiously and require confirmation in prospective studies specifically designed to address the effect of recent hospitalization on treatment benefit. Finally, our focus was on hard cardiovascular endpoints; effects on patient-reported outcomes remain an important area for future study.
5 Conclusion
This exploratory, hypothesis-generating analysis suggests that in patients with HFpEF recently hospitalized for heart failure, SGLT2 inhibitors may reduce the risk of cardiovascular death or HF rehospitalization. A similar direction of effect was observed across two definitions of “recent” hospitalization (≤30 days and ≤12 months). However, due to the exploratory nature of the analysis and the lack of a validated comparison across trials, these findings should be interpreted cautiously and require confirmation in prospective studies specifically designed to address the timing of therapy initiation.
Statements
Data availability statement
The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found in the article/Supplementary Material.
Ethics statement
This study is a secondary analysis of data from the EMPEROR-Preserved (NCT03057951) and DELIVER (NCT03619213) trials. Both trials were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocols were approved by the ethics committee or institutional review board at each participating centre, and all enrolled patients provided written informed consent. No separate ethics approval was required for this pooled analysis of de-identified, trial-level data. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.
Author contributions
XX: Data curation, Formal analysis, Writing – original draft, Writing – review & editing. MH: Methodology, Supervision, Writing – review & editing. JC: Software, Validation, Writing – review & editing. JL: Project administration, Visualization, Writing – review & editing. WZ: Conceptualization, Funding acquisition, Writing – review & editing.
Funding
The author(s) declared that financial support was received for this work and/or its publication. The author(s) declared that this work received funding from Boehringer Ingelheim, Eli Lilly and Company, and AstraZeneca for the original EMPEROR-Preserved and DELIVER trials. The funders were not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication. The present prespecified, trial-level pooled analysis was supported by the Zhejiang Traditional Chinese Medicine Science and Technology Plan Project (Grant Number 2023ZL346).
Conflict of interest
The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Generative AI statement
The author(s) declared that generative AI was not used in the creation of this manuscript.
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Supplementary material
The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fcvm.2026.1816804/full#supplementary-material
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Summary
Keywords
heart failure hospitalization, heart failure with preserved ejection fraction, high-risk patients, pooled analysis, SGLT2 inhibitors
Citation
Xue X, Hu M, Chi J, Li J and Zhang W (2026) Efficacy of SGLT2 inhibitors in patients recently hospitalized for heart failure: an exploratory prespecified pooled analysis of the DELIVER and EMPEROR-preserved trials. Front. Cardiovasc. Med. 13:1816804. doi: 10.3389/fcvm.2026.1816804
Received
24 February 2026
Revised
09 April 2026
Accepted
28 April 2026
Published
12 May 2026
Volume
13 - 2026
Edited by
Massimo Iacoviello, University of Foggia, Italy
Reviewed by
Jorge Balaguer German, University Hospital Fundación Jiménez Díaz, Spain
Xuan Ci Mee, Mayo Clinic Arizona, United States
Updates
Copyright
© 2026 Xue, Hu, Chi, Li and Zhang.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Wei Zhang vivian_zhang28@126.com
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.