About Heart Failure
Approximately 63 million people live with heart failure worldwide. In heart failure, the ability of the heart to fill and empty is compromised, causing shortness of breath, fatigue, swelling in the legs, and difficulty with activities of daily living.
While many people with heart failure have severely compromised ability for the heart to pump (a reduced ejection fraction), about half of all people with heart failure have only mildly reduced or even preserved ejection fraction, yet have similar symptoms as with those with reduced ejection fraction. While therapies for heart failure with reduced ejection fraction have been available for some time, few therapies have been demonstrated to benefit patients with heart failure and mildly reduced or preserved ejection fraction.
What was DELIVER?
DELIVER was a randomized, placebo-controlled, double-blind international clinical outcomes trial testing the hypothesis that dapagliflozin compared with placebo would reduce the risk of cardiovascular death or worsening heart failure in patients with heart failure with mildly reduced or preserved ejection fraction.
Patients were eligible if they had heart failure with LVEF > 40%, evidence of structural heart disease and elevated natriuretic peptides. Patients could be enrolled if ambulatory, hospitalized or recently hospitalized and patients with prior LVEF of 40% or less were eligible if their LVEF had improved to over 40% by enrollment.
What did DELIVER show?
DELIVER randomized 6263 patients with heart failure with mildly reduced or preserved ejection fraction to dapagliflozin or placebo and followed these patients for a median of 2.3 years. Vital status was known at the end of the study on all but 4 patients. Dapagliflozin reduced the composite endpoint of cardiovascular death or worsening heart failure by 18% (HR 0.82, 95% CI 0.73 to 0.92). Importantly, this benefit was seen irrespective of ejection fraction (without attenuation in the highest LVEF range), or care setting (ambulatory or hospitalized) and patients with heart failure with improved ejection fraction derived benefit to a similar extent as patients with LVEF consistently over 40%.
What do the DELIVER findings mean for patients?
The results of DELIVER, taken together with the results from DAPA-HF, suggest that dapagliflozin can benefit patients across the spectrum of ejection fraction and that SGLT2 inhibitors should be considered foundational therapy in patients with heart failure irrespective of ejection fraction or care setting.