DELIVER Design and Results
Study Design
DELIVER was a randomized, double blind, placebo-controlled trial testing the hypothesis that dapagliflozin would reduce cardiovascular death or worsening heart failure in patients with heart failure and mildly reduced or preserved ejection fraction
Eligibility Criteria
To be eligible for DELIVER patients had to fulfill the following criteria:
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Age of 40 years or older
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NYHA Class II-IV heart failure
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LVEF > 40% (including prior LVEF of 40% or under that had improved to over 40%)
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Structural heart disease (LVH or LA Enlargement)
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Elevated Natriuretic Peptides (> 300 pg/ml or 600 pg/ml if in atrial fibrillation or flutter)
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Patients could be either ambulatory, hospitalized or recently hospitalized
See full design details in the design manuscript
Primary Results
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6263 patients randomized and followed for a median of 2.3 years, 2 patients per group lost to follow-up
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Dapagliflozin reduced cardiovascular death or worsening heart failure by 18% (HR 0.82, 95% CI 0.73 to 0.92, p = 0.0008)
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Results were consistent regardless of ejection fraction, with no attenuation in patients with higher LVEF, and consistent across care setting and in all other pre-specified subgroups
See full results in primary manuscript in the New England Journal of Medicine
