Cardiovascular Atlas
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DELIVER

A large trial in adults with heart failure and an ejection fraction above 40%, which covers mildly reduced and preserved values. About half were given dapagliflozin 10 mg once a day and half a placebo, on top of usual treatment. Over a median of 2.3 years, fewer people on dapagliflozin had worsening heart failure or died from cardiovascular causes. When cardiovascular death was counted on its own, the abstract reports a hazard ratio of 0.88 with a confidence interval that includes 1.

Also called Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, double-blind, placebo-controlled phase 3 study of dapagliflozin 10 mg once daily added to usual therapy in people with an ejection fraction above 40%. The registry records masking as quadruple.
Phase
Phase 3
Enrolled
  • 6,263 patients (randomized count) (Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03619213
Started
(actual) (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure., retrieved )
Primary completion
(actual) (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure., retrieved )
Completion
(actual) (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure., retrieved )
Results first posted
(actual) (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure., retrieved )
Countries
United States, Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Hungary, Japan, Mexico, Netherlands, Peru, Poland, Romania, Russia, Saudi Arabia, Spain, Taiwan, Vietnam (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure., retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

AstraZeneca-sponsored, randomized, placebo-controlled phase 3 study (NCT03619213) of 6263 patients with heart failure and a left ventricular ejection fraction of more than 40%. Primary outcome: worsening heart failure or cardiovascular death, hazard ratio 0.82 (95% CI 0.73 to 0.92) over a median of 2.3 years, from the PubMed abstract. Worsening heart failure alone: hazard ratio 0.79 (95% CI 0.69 to 0.91). Cardiovascular death alone: hazard ratio 0.88 (95% CI 0.74 to 1.05). The registry condition and title say preserved ejection fraction, while the abstract title says mildly reduced or preserved. The full text was not read. Funding is stated in the abstract as AstraZeneca.

Arms

  • Dapagliflozin

    Intervention Dapagliflozin

    Dapagliflozin 10 mg once daily, added to usual therapy (abstract).

  • Placebo

    Intervention None named

    Matching placebo, added to usual therapy (abstract and registry).

Findings

No findings are published for this study.

Record details

Record id
cardio:deliver
Content hash
e1268e0727fac8f8c656b3f3627b30c70105a64a0c2c6be488235b785504e3c6