Summary: This is the published rationale and design of DAPA ACT HF-TIMI 68, an international randomised, double-blind trial enrolling 2,401 patients hospitalised for acute heart failure to in-hospital initiation of dapagliflozin 10 mg daily versus placebo over two months. The primary efficacy endpoint is the time to first cardiovascular death or worsening heart failure. No efficacy or safety results are reported in this design paper; the figures below describe the planned protocol, not proven outcomes.
PICO Summary
| Element | Detail |
|---|---|
| Population | 2,401 patients hospitalised for acute heart failure (de novo or worsening chronic), enrolled irrespective of left ventricular ejection fraction or type 2 diabetes status; international, multicentre, randomised double-blind trial (NCT04363697). |
| Intervention | In-hospital initiation of dapagliflozin 10 mg once daily, blinded treatment for two months (planned arm; per-arm n not specified in the design paper). |
| Comparison | Matching placebo, blinded for two months (planned arm; per-arm n not specified in the design paper). |
| Outcome | Planned primary efficacy endpoint: time to first cardiovascular death or worsening heart failure (worsening HF during index admission, rehospitalisation for worsening HF, or urgent HF visit). Key planned safety endpoints: symptomatic hypotension and worsening kidney function. No effect estimate, confidence interval, p value, ARR or NNT is available, as results have not been reported in this paper. |
Expert Commentary
This article is a protocol and design publication, not a results report, and it should be read as a statement of intent rather than evidence of benefit. The verdict is that nothing here demonstrates that in-hospital dapagliflozin changes outcomes in acute heart failure; the document simply specifies how the question will be tested. It is framed as the first cardiovascular outcomes trial designed specifically around in-hospital initiation, which is a genuine evidence gap given that prior SGLT2 inhibitor data were generated largely in chronic, ambulatory heart failure. The design is methodologically reassuring on paper, being randomised, double-blind and placebo-controlled, with an ejection-fraction-agnostic and diabetes-agnostic population that mirrors the real inpatient ward. The principal limitation worth weighing is the short two-month blinded window, which is well suited to capturing early in-hospital events but cannot speak to durable benefit, longer-term safety, or adherence after discharge. Sponsorship and the involvement of a trialist group with strong ties to the manufacturer of dapagliflozin warrant the usual caution about framing, and readers should wait for the locked, peer-reviewed primary results before drawing conclusions. Can I use this with my patients? Not yet; this paper supports no change in practice, and SGLT2 inhibitor initiation in a hospitalised acute heart failure patient should still follow current guidelines and clinical judgement. The sensible course is to await the reported efficacy and safety endpoints before acting.
References
Berg DD, Patel SM, Haller PM, et al. Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial. JACC Heart Fail. 2025;13(5):829-839. doi:10.1016/j.jchf.2025.03.014