# DAPA-HF: what the trial showed

Canonical page: https://cliniatlas.com/trials/dapa-hf/

In 4,744 patients with symptomatic heart failure and an ejection fraction of 40% or less, dapagliflozin 10 mg daily on top of recommended therapy reduced worsening heart failure or cardiovascular death from 21.2% to 16.3% over a median of 18.2 months, with and without diabetes.

**Main cited publication:** Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine (2019). PMID 31535829. https://pubmed.ncbi.nlm.nih.gov/31535829/

## At a glance

- Design: Phase 3, randomised, double-blind, placebo-controlled, event-driven
- Population: 4,744 adults with NYHA class II to IV heart failure and a left ventricular ejection fraction of 40% or less, with or without type 2 diabetes, on recommended heart failure therapy
- Intervention: Dapagliflozin 10 mg once daily
- Comparator: Placebo
- Follow-up: Median 18.2 months
- Registration: NCT03036124
- Funding: AstraZeneca

## Primary outcome

Composite of worsening heart failure (hospitalisation or urgent visit needing intravenous therapy) or cardiovascular death.

- Dapagliflozin 10 mg once daily: 16.3% (386 of 2,373)
- Placebo: 21.2% (502 of 2,371)
- Effect: Hazard ratio 0.74 (95% CI 0.65 to 0.85), P<0.001

## Key findings

- A first worsening heart failure event occurred in 10.0% with dapagliflozin and 13.7% with placebo (HR 0.70, 95% CI 0.59 to 0.83).
- Cardiovascular death occurred in 9.6% versus 11.5% (HR 0.82, 95% CI 0.69 to 0.98), and all-cause death in 11.6% versus 13.9% (HR 0.83, 95% CI 0.71 to 0.97).
- The effect was similar in patients with and without type 2 diabetes, which established SGLT2 inhibition as a heart failure treatment rather than a glucose-lowering strategy.
- The absolute reduction in the primary outcome was about 4.9 percentage points over the trial period, roughly one event prevented for every 21 patients treated for 18 months.

## Harms and safety

- Adverse events related to volume depletion, renal dysfunction, and hypoglycaemia did not differ between groups.
- The abstract does not report an excess of serious adverse events with dapagliflozin.

## Limitations

- Median follow-up was 18 months, so longer-term effects and rare harms are not captured by the primary publication.
- Patients were already on recommended therapy in a trial setting; real-world populations are older, with more comorbidity and lower adherence.
- Industry funded and placebo controlled; there is no head-to-head comparison with other SGLT2 inhibitors.

## Where it sits in guidelines

The 2021 ESC heart failure guideline gives dapagliflozin and empagliflozin a class I recommendation in symptomatic HFrEF, as one of the four pillars of therapy alongside an ACE inhibitor or ARNI, a beta-blocker, and an MRA, largely on the strength of DAPA-HF and EMPEROR-Reduced.

## CliniAtlas answers that use this trial

- https://cliniatlas.com/evidence/sglt2-inhibitors-heart-failure-reduced-ejection-fraction/

Ask about this trial against live sources (free, no sign-in): https://cliniatlas.com/?q=What%20did%20the%20DAPA-HF%20trial%20show%20and%20how%20should%20it%20be%20interpreted%3F

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