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DAPA-HF

A large trial in adults with heart failure and a reduced ejection fraction (40% or less) who were already taking recommended treatment. About half were given dapagliflozin 10 mg once a day and half a placebo. Over a median of about 18 months, fewer people on dapagliflozin had worsening heart failure or died from cardiovascular causes. The authors report similar findings in people with and without diabetes.

Also called Dapagliflozin and heart failure with reduced ejection fraction trial

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, placebo-controlled phase 3 trial of dapagliflozin 10 mg once daily added to recommended therapy. The registry records masking as quadruple and the primary purpose as treatment.
Phase
Phase 3
Enrolled
  • 4,744 patients (randomized count) (Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03036124
Started
(actual) (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure, retrieved )
Primary completion
(actual) (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure, retrieved )
Completion
(actual) (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure, retrieved )
Results first posted
(actual) (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure, retrieved )
Countries
United States, Argentina, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Germany, Hungary, India, Japan, Netherlands, Poland, Russia, Slovakia, Sweden, Taiwan, United Kingdom, Vietnam (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic 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 trial (NCT03036124) of 4744 patients with NYHA class II to IV heart failure and an ejection fraction of 40% or less. Primary outcome: worsening heart failure (hospitalization or an urgent visit with intravenous therapy) or cardiovascular death, hazard ratio 0.74 (95% CI 0.65 to 0.85) over a median of 18.2 months, from the PubMed abstract. The full text was not read. The registry holds a results section that this record does not extract. Funding is stated in the abstract as AstraZeneca.

Arms

  • Dapagliflozin

    Intervention Dapagliflozin

    Dapagliflozin 10 mg once daily, added to recommended therapy (abstract). The registry says patients were randomized 1:1 to dapagliflozin or placebo.

  • Placebo

    Intervention None named

    Placebo matching dapagliflozin, added to recommended therapy (registry and abstract).

Findings

No findings are published for this study.

Record details

Record id
cardio:dapa-hf
Content hash
1a0f83d314a7ad8d89c66ac1caf76d721ddbf9be0f99b9f83455b26f5f8b7445