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Effect of In-Hospital Initiation of Dapagliflozin on Decongestion in Patients Hospitalized for Heart Failure
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Key result
In-hospital dapagliflozin reduces early congestion score by 0.18 points over placebo at 1 week.
- LSMD -0.18
- 95% CI -0.33 to -0.04
- P=0.011
- n=2,401
Why the study?
Safe and effective decongestion remains an important therapeutic goal in patients hospitalized for heart failure.
Does in-hospital initiation of dapagliflozin improve decongestion in patients hospitalized for heart failure?
Key Points
- To evaluate the effect of in-hospital initiation of dapagliflozin on multiple clinically relevant measures of congestion in patients hospitalized for heart failure.
- Prespecified analysis of DAPA ACT HF-TIMI 68 (NCT04363697), a randomized, double-blind, placebo-controlled trial enrolling 2,401 patients hospitalized for heart failure randomized 1:1 to dapagliflozin (10 mg once daily) or matching placebo after initial clinical stabilization.
- Evaluated placebo-adjusted changes from baseline in modified Composite Congestion Score (CCS), body weight, mean daily loop diuretic dose (furosemide 40 mg IV equivalents), and diuretic efficiency at 1 week, 1 month, and 2 months using linear mixed-effects models for repeated measures.
- At 1 week, dapagliflozin significantly improved decongestion endpoints versus placebo: CCS (LSMD: -0.18; 95% CI: -0.33 to -0.04; P = 0.011), body weight (LSMD: -0.60 kg; 95% CI: -0.95 to -0.26; P < 0.001), and loop diuretic dose (LSMD: -0.12 furosemide 40-mg IV equivalents; 95% CI: -0.22 to -0.02; P = 0.014).
- Diuretic efficiency was significantly improved by dapagliflozin at 1 week (LSMD: -0.93 kg/furosemide 40 mg IV equivalents; 95% CI: -1.61 to -0.25; P = 0.008) and demonstrated progressive enhancement through 2 months (LSMD: -1.99 kg/furosemide 40 mg IV equivalents; 95% CI: -3.19 to -0.78; P < 0.001).
Study Design
Type
RCT (n=2,401)
Blinding
double-blind, placebo-controlled
Randomization
1:1 ratio
Multicenter
Yes
Structured PICO
Does in-hospital initiation of dapagliflozin improve decongestion in patients hospitalized for heart failure?
P
Population
2,401 adults hospitalized for heart failure with signs of fluid overload and elevated natriuretic peptides, followed for 2 months.
I
Intervention
Dapagliflozin 10 mg oral once daily initiated in-hospital
C
Comparator
Matching placebo
O
Outcome
Placebo-adjusted change from baseline in modified EVEREST Composite Congestion Score (CCS) at 1 weeksurrogate
Main Result
Mean Difference: -0.18 (95% CI -0.33–-0.04)
p-value: p=0.011
In-hospital initiation of dapagliflozin provides early and sustained improvements in decongestion and diuretic efficiency in patients hospitalized for heart failure.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The totality of randomized trial data really suggests that starting SGLT2 inhibitors during heart failure hospitalization reduces the early risk of cardiovascular death or worsening heart failure and all-cause mortality in the early postdischarge period.”
“In-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF over the first two months in DAPA ACT HF-TIMI 68. However, the totality of trial data suggests that in-hospital initiation of an SGLT2i reduces the early risk of cardiovascular death or worsening HF and all-cause mortality.”
“In-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF over the first 2 months in DAPA ACT HF-TIMI 68.”
Implication
Supports in-hospital dapagliflozin initiation to speed decongestion in acute HF; extends prior SGLT2i trials to early congestion endpoints.
Abstract
BACKGROUND: Safe and effective decongestion remains an important therapeutic goal in patients hospitalized for heart failure. OBJECTIVES: The authors evaluated the effect of dapagliflozin on multiple clinically relevant measures of congestion among patients hospitalized for heart failure. METHODS: This was a prespecified analysis of DAPA ACT HF-TIMI 68 (Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure-Thrombolysis in Myocardial Infarction 68), a randomized, placebo-controlled trial evaluating in-hospital initiation of dapagliflozin on clinical outcomes through 2 months. The authors assessed placebo-adjusted changes from baseline in modified EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure) Composite Congestion Score (CCS), body weight, mean daily loop diuretic dose (furosemide 40 mg intravenous [IV] equivalents), and body weight adjusted for mean daily loop diuretic dose (diuretic efficiency) at 1 week, 1 month, and 2 months using linear mixed-effects models for repeated measures. RESULTS: At randomization, 12%, 63%, and 24% had no congestion (CCS 0), mild-to-moderate congestion (CCS 1-3), and severe congestion (CCS 4-9), respectively. Compared with placebo, dapagliflozin improved all decongestion-related endpoints by 1 week, including CCS (least squares mean difference [LSMD]: -0.18; 95% CI: -0.33 to -0.04; P = 0.011), body weight (LSMD: -0.60 kg; 95% CI: -0.95 to -0.26; P < 0.001), mean daily loop diuretic dose (LSMD: -0.12 furosemide 40-mg IV equivalents; 95% CI: -0.22 to -0.02; P = 0.014), and diuretic efficiency (LSMD: -0.93 kg/furosemide 40 mg IV equivalents; 95% CI: -1.61 to -0.25; P = 0.008). These improvements were sustained through 2 months, with progressive increases in diuretic efficiency through 2 months (LSMD: -1.99 kg/furosemide 40 mg IV equivalents; 95% CI: -3.19 to -0.78; P < 0.001). CONCLUSIONS: In-hospital initiation of dapagliflozin led to modest but significant improvements across multiple measures of congestion within 1 week that were sustained through 2 months. Diuretic efficiency progressively improved through 2 months. (Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure-Thrombolysis in Myocardial Infarction 68 [DAPA ACT HF-TIMI 68]; NCT04363697).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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Cite This Study
Small et al. (2026) conducted an RCT in Heart failure (n=2,401). Dapagliflozin vs. Matching placebo was evaluated on Placebo-adjusted change from baseline in modified EVEREST Composite Congestion Score (CCS) at 1 week (LSMD -0.18, 95% CI -0.33 to -0.04, p=0.011). In-hospital initiation of dapagliflozin significantly improved the modified EVEREST Composite Congestion Score at 1 week compared with placebo (LSMD -0.18, p=0.011).
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