drugset / Trial / NCT04363697
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
Phase 4
Completed
2401 enrolled
The TIMI Study Group
AstraZeneca · collabWorldwide Clinical Trials · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
This is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.
Timeline
- Start
- 2020-09-24
- Primary completion
- 2025-06-02
- Completion
- 2025-06-02
Outcome
Missed primary endpoint
registry p = 0.20; Hazard Ratio (HR) 0.86 (95% CI 0.68 to 1.08) NCT04363697 ↗
paper In this trial, in-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF through 2 months PMID 40884036 ↗
Publications
- Results Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
- Berg DD, Patel SM, Haller PM, Cange AL, Palazzolo MG, Bellavia A, Kuder JF, Desai AS, Inzucchi SE, McMurray JJV, O'Meara E, Verma S, Belohlavek J, Drozdz J, Merkely B, Ogunniyi MO, Drasnar T, Izzo JL, Sarman B, McGinty JE, Ramanathan K, Mulkay AJ, Przybylski A, Ruff CT, O'Donoghue ML, Murphy SA, Sabatine MS, Wiviott SD; DAPA ACT HF-TIMI 68 Trial Committees and Investigators. Dapagliflozin in Patients Hospitalized for Heart Failure: Primary Results of the DAPA ACT HF-TIMI 68 Randomized Clinical Trial and Meta-Analysis of Sodium-Glucose Cotransporter-2 Inhibitors in Patients Hospitalized for Heart Failure. Circulation. 2025 Nov 18;152(20):1411-1422. doi: 10.1161/CIRCULATIONAHA.125.076575. Epub 2025 Aug 29.
- Berg DD, Patel SM, Haller PM, Belohlavek J, Desai AS, Drozdz J, Inzucchi SE, McMurray JJV, Merkely B, O'Meara E, Verma S, Cange AL, Murphy SA, Sabatine MS, Wiviott SD. Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial. JACC Heart Fail. 2025 May;13(5):829-839. doi: 10.1016/j.jchf.2025.03.014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |